CrawlJobs Logo
Edgerton Dental Clinic Logo Edgerton Dental Clinic · IT - Administration

Associate Regulatory Specialist II

Poland, Kraków · Job Posted May 05, 2026
Apply Position
Job Link Share

Job Description

Ecolab is seeking to hire an Associate Regulatory Specialist II/Engineer located at our Krakow, Poland office. We are looking for the right candidate that has engineering experience. They will be responsible for ensuring our equipment complies with local regulatory requirements. They will work with cross-functional project teams to ensure compliance with our equipment and packaging. Their main duties will be organizing regulatory approvals for equipment (dispensers, controllers, wireless devices, pumps) in EU countries using local network support or laboratories/product certification services.

Job Responsibility

  • Lead and coordinate efforts to ensure equipment satisfies appropriate testing standards mandatory for placing in the market
  • Obtain Drinking Water Directive and local Drinking Water Approvals
  • Create and maintain equipment technical files documenting equipment regulatory compliance meeting Machine Regulation requirements
  • Support Packaging & Packaging Waste Regulation (PPWR) by identifying requirements through building technical files
  • Define equipment in scope for WEEE and report of sales data to the authorities
  • Collect compliance documentation from suppliers (Reach, RoHS, EU DoC, Drinking Water)
  • Will work in close collaboration with larger EU Team to complete projects across all divisions
  • Organize laboratories and product certification agencies for testing equipment

Requirements

  • Bachelor’s degree in electrical/Electronics/Industrial/Mechanical or Telecommunication Engineering
  • 2+ years of professional work experience working at a certification agency, testing lab or coordinating regulatory approvals
  • Able to clearly explain project status and hurdles
  • Experience in navigating cross functional teams to obtain results
  • Comfortable to perform administrative tasks like documentation collection, organizing files, and creating record documents
  • Project management experience
  • Familiar with extracting information from SAP, Excel, and Power Point
  • Used to work in virtual environment like Microsoft Teams and lead virtual meetings in English
  • Fluency in English

Nice to have

  • 2+ years of experience working in a certification agency or testing lab or coordinating equipment regulatory approvals or related equipment compliance activity
  • Knowledge of European Regulations (Machinery, PPWR, ATEX, LVD, RoHS, WEEE, EMC)
  • Knowledge of telecommunications approvals (RED, FCC, type approval)
  • Strong interpersonal and networking skills
  • Savvy with knowledge management programs
  • Fluent in German language

What we offer

  • Competitive Compensation: Attractive salary (Base pay & Variable Plan) and benefits package (private medical care, life insurance, stock purchase, lunch subsidy, sport cards)
  • Work-Life Balance: Flexible working arrangements with hybrid model of work (approx. 60% from the office and 40% from home)
  • Matrix Organization: Thrive in our matrix organization, working across Europe with various teams and cultural backgrounds
  • Collaborative Environment: Strong teamwork and diverse interactions
  • Development Opportunities: Personalized plans with rapid progression
  • Versatile Career Paths: Professional growth supported by active committee for different career levels
  • Supportive Culture: High employee satisfaction and responsive feedback
  • Learning and Innovation: Continuous learning and technical training incl. subject matter experts’ trainings, soft skills and management trainings and LinkedIn learning
  • Relocation Support: Assistance for international candidates and candidates living outside of Krakow
  • Social events such as family events and charity auctions
  • Comfortable working environment (Library, relaxation area, casual dress code)
  • Parking space for cars and bikes
Edgerton Dental Clinic - All Job Offers

Looking for more opportunities?

Search for other job offers that match your skills and interests.

Suggested Tags: Frontend Developer Secretary Talent Manager Salesforce Administrator Data Analyst
Similar Jobs for

Associate Regulatory Specialist II

8 matching positions

New

Senior Clinical Research Associate/Clinical Research Associate II - Oncology

As a Clinical Research Associate (CRA) at Parexel, you act as an integral part t...
Location
Location
United States
Salary
Salary:
Not provided
parexel.com Logo
Parexel
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology) in a CRO or pharma organization
  • Preferred therapeutic experience in Oncology
  • Global clinical trial experience preferred
  • Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
  • Must be fluent in English and in the native language(s) of the country they will work in
  • Travel (60-80%) within area is required
  • Valid driver’s license and passport required
  • Demonstrated knowledge of clinical research and development processes and ability to gain command of process details
  • Demonstrated knowledge of global and local regulatory requirements
  • Demonstrated understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.)
Job Responsibility
Job Responsibility
  • Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and sponsor standards to achieve project goals, timelines and quality
  • Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met
  • During study conduct, serve as the primary point of contact for assigned investigator sites
  • Work in partnership with and/or escalate to the SCP to ensure quality of site delivery
  • Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
  • Partner with SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients
  • Provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks
  • Attend investigator meeting when required (virtual or F2F)
  • Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators
  • Partner with SCP and the study team to define and support recruitment initiatives at site level
What we offer
What we offer
  • Flexible work arrangements
  • Career growth and development
  • Supportive and inclusive environment
  • Diverse therapeutic areas and project exposure
  • Advanced Technology
  • Fulltime
Read More
Arrow Right

Global Regulatory Specialist

As a Global Regulatory Specialist, you will join our Quality & Regulatory Affair...
Location
Location
Sweden , Stockholm
Salary
Salary:
Not provided
Tobii Dynavox
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • A bachelor’s degree in Regulatory Affairs, Life Sciences, Electrical-Electronics or a related field
  • At least 5 years of experience in medical device regulatory affairs with hands-on experience with EU MDR (Class I) and FDA QSR
  • Experience with regulatory systems, document control tools, and QMS platforms and exposure to technical documentation, internal and external audits for regulatory compliance
  • Strong organization, coordination and communication skills to engage auditors and communicating with stakeholders across functions and levels
  • Ability to break down complex regulatory topics clearly for both technical and non-technical stakeholders
  • Proficiency in both spoken and written communication in English
Job Responsibility
Job Responsibility
  • Streamline regulatory processes and set a roadmap in collaboration Product & Development, QA, and Operations teams
  • Coordinate with internal and external auditors to support audit readiness
  • Review device classifications and regulatory challenges across markets
  • Maintain and update technical documentation (Annex II & III) and declarations of conformity, including EU Declaration of Conformity, in alignment with the associated technical documentation
  • Coordinate establishment of registrations and device listings with the FDA, Authorized Representatives, and Importers/Distributors
  • Support product registrations and market access activities (EU MDR Class I, FDA 510(k)-exempt Class II)
  • Monitor regulatory changes and communicate implications to relevant teams
  • Fulltime
Read More
Arrow Right

Sshe Specialist II

Safety, Security, Health, and Environment (SSHE) Specialists not only support on...
Location
Location
United States , Williston
Salary
Salary:
Not provided
airswift.com Logo
Airswift Sweden
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Behavioral Skills: analytical, communicates effectively, courage of conviction, manages risk
  • Functional Skills: emergency preparedness and response, incident investigation and analysis, operations integrity and compliance assessment, OIMS execution support, risk assessment and management, safety management, safety regulations and standards, fundamentals of health, fundamentals of environmental management and regulatory compliance, environmental standards, regulation development and advocacy, SSHE management - operations and maintenance, managing critical operations activities
  • Associate or Bachelor’s degree required
  • Demonstrated work experience in safety-related positions (including some prior oil & gas experience)
  • Knowledge of security processes and procedures
  • Proficient in use of computers and programs such as PowerPoint, Excel, Word and Microsoft Office
  • Read, write, and speak fluent English, as required to function effectively within a project team
Job Responsibility
Job Responsibility
  • Assist the workforce in the implementation of SSHE Processes, Safety Instructions, Safety Procedures, and hazard management strategies as well as ensure compliance with project plans and other relevant company programs
  • Encourage and facilitate an appropriate level of workforce participation in the application of SSHE processes
  • Proactively identify SSHE related issues at the project site and facilitate effective resolution of any issues
  • Participate in contractor qualification process and other SSHE activities as requested by SSHE Lead
  • Provide review and comment, as appropriate, on project specific procedures and manuals
  • Management, inspection and maintenance of SHE Critical Equipment (fire response, oil spill response, portable gas detection, life boats, life rafts, life vests etc.)
  • Review of annual ERT drill program and feedback to central OIMS team and System 10-2 Administrator. Communication of Emergency Response Plans to ERT and other relevant personnel
  • Coordination of emergency response teams in conjunction with On Scene Coordinator (OSC) during emergency scenarios. Manages forward control (FCP) during emergency situations
  • Fulltime
Read More
Arrow Right

Office Support Specialist II

To provide fair and consistent regulation of insurance producers, adjusters, and...
Location
Location
United States , Cheyenne
Salary
Salary:
22.63 - 24.74 USD / Hour
dot.state.wy.us Logo
Wyoming Department of Transportation
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Associate's Degree (typically in Business)
  • 0-2 years of progressive work experience (typically in Business Office Communications) with acquired knowledge at the level of an Office Support Specialist I
  • OR 2-4 years of progressive work experience (typically in Business Office Communications) with acquired knowledge at the level of an Office Support Specialist I
  • Basic knowledge of computer applications, including Google suite and internet browsers
  • Ability to communicate clearly and professionally in writing and verbally
  • Knowledge of state laws and regulations governing insurance licensing
  • Knowledge of Department policies and practices relative to the licensing of individuals and firms
  • Knowledge of continuing education requirements
  • Knowledge of insurance industry terms, general practices, and procedures
  • Ability to prioritize assigned work and multi-task under pressure with constant interruptions
Job Responsibility
Job Responsibility
  • Review and analyze insurance license applications for individuals and corporations through interpretation of insurance statutes, regulations, and Department guidelines to determine eligibility for licensure
  • Process eligible applications and enter all necessary information into the Department database
  • Compose and relay correspondence relating to licensing
  • Process appointments, terminations, letters of clearance, and other miscellaneous licensing requests
  • Review and process renewal applications and required attachments and disclosures for continued eligibility for licensing, rejecting those that do not meet the required standards
  • Review continuing education provider and course applicants and renewals submitted for approval
  • Assist licensees regarding continuing education compliance
  • Extensive email, telephone, and in-person contact with applicants, licensees, insurance companies, state agencies, and other regulatory departments to provide information on licensing forms, procedures, testing, and education requirements pursuant to state laws and regulations
  • Participate in licensing team meetings and projects
  • Act as a resource to provide information or interpretation of specific rules/regulations to Department staff, members of the public, or other government entities
What we offer
What we offer
  • Comprehensive health, dental, and vision insurance
  • Paid vacation, sick leave, FMLA, and holidays
  • Retirement - Pension and 457B plans
  • Fulltime
Read More
Arrow Right

Specialist II, Product Quality Assurance

The Specialist, NC Product Quality Assurance (PQA) will be responsible for suppo...
Location
Location
United States , Durham, NC
Salary
Salary:
105000.00 - 145000.00 USD / Year
beamtx.com Logo
Beam Therapeutics
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelors or Advanced degree in a scientific discipline
  • 10+ years’ experience in the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture, development and/or quality
  • Knowledge of aseptic processing, and/or cell and gene therapy is preferred
  • Apply Quality concepts and company policies to resolve issues of moderate complexity in an effective manner
  • Excellent verbal and written communication skills, detail-oriented personality, and ability to work collaboratively across functions
  • Knowledge of global regulations and standards
  • Strong team player that has a customer service approach and is solution oriented
  • Attention to detail and the ability to work individually as well as within a multi-disciplinary team
  • Excellent listening, communication and interpersonal skills with a team focus
  • Consistent delivery of high-quality work
Job Responsibility
Job Responsibility
  • Provide Quality oversight of on-the-floor activities including manufacturing shop floor presence during operations
  • Provide Quality oversight of QC testing
  • Responsible for ensuring GMP compliance with applicable procedures and production requirements in QC, manufacturing, and facilities operations
  • Responsible for assisting with product disposition activities of supply produced at the manufacturing facility
  • Real time review of batch records and labels
  • Review and approval of manufacturing discrepancies and associated CAPA’s
  • Communicating lot disposition pending issues to management
  • Aid in the development and ongoing improvement of applicable quality systems for the site
  • identifying gaps or improvements, authoring and approval of procedures, and providing training, as needed
  • Review and approve calibration and maintenance work orders and asset inductions
  • Fulltime
Read More
Arrow Right

Senior Clinical Research Associate II - FSP

As a Clinical Research Associate (CRA) at Parexel, you act as an integral part t...
Location
Location
Turkey
Salary
Salary:
Not provided
parexel.com Logo
Parexel
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
  • Monitoring Experience: Minimum 5 years relevant experience in clinical research site monitoring (preferably 3 years in Oncology)
  • Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
  • Global clinical trial experience
  • Must be fluent in English and in the native language(s) of the country they will work in
  • Significant travel (60-80%) within area is required. May require some international travel and some weekend travel
  • Valid driver’s license and passport required
  • Demonstrated knowledge of clinical research and development processes and ability to gain command of process details
  • Demonstrated knowledge of global and local regulatory requirements
  • Demonstrated understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.)
Job Responsibility
Job Responsibility
  • Oversight of Monitoring Responsibilities and Study Conduct
  • Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and client standards to achieve project goals, timelines and quality
  • Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met
  • During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery
  • Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
  • Partner with SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients
  • provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks
  • Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators. Partner with SCP and the study team to define and support recruitment initiatives at site level
  • Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies
  • Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution
What we offer
What we offer
  • Flexible work arrangements
  • Career growth and development
  • Supportive and inclusive environment
  • Diverse therapeutic areas and project exposure
  • Advanced Technology
Read More
Arrow Right
New

Associate Director - Specialist Modelling

We’re Hiring Associate Director – Specialist Modelling up to £100,000 plus bonus...
Location
Location
United Kingdom , South West London
Salary
Salary:
93500.00 - 110000.00 GBP / Year
socialvalueportal.com Logo
Social Value Portal Ltd
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Strong financial services modelling and analytics experience
  • Expertise in cashflow modelling, derivatives, and balance sheet products
  • Knowledge of regulatory frameworks (e.g. IFRS 9, Basel, BCBS239) SOL II, CRD V
  • Proven leadership, stakeholder management, and delivery skills
  • Ability to translate complex technical insights into clear business value
Job Responsibility
Job Responsibility
  • Lead high-impact modelling, model validation, and data analytics engagements
  • Apply expertise in loan book profiling, EIR curve modelling, and derivatives/hedging
  • Deliver robust data assurance and insights using Python, SQL, Excel, and visualisation tools (Tableau/Power BI)
  • Collaborate with senior stakeholders and global teams to solve complex financial challenges
  • Mentor teams, shape strategy, and drive innovation across engagement
What we offer
What we offer
  • bonus & benefits
  • Fulltime
Read More
Arrow Right
New

Appeals and Grievances Nurse Specialist RN II

The Appeals and Grievances (A&G) Nurse Specialist Registered Nurse (RN) II provi...
Location
Location
United States , Los Angeles
Salary
Salary:
88854.00 - 142166.00 USD / Year
lacare.org Logo
L.A. Care Health Plan
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Associate's Degree in Nursing
  • At least 5 years of experience in Clinical RN
  • At least 2 years in Medicare/ Medicaid in a managed care/ health plan environment
  • Excellent interpersonal and communication skills
  • Computer literacy and adaptability to computer learning
  • Time management and priority setting skills
  • Must be organized and a team player
  • Able to work effectively with various internal departments/service areas, L.A. Care's plan partners, participating provider groups, and other external agencies
  • Good working knowledge of regulatory requirements/standards
  • Registered Nurse (RN) - Active, current and unrestricted California License
Job Responsibility
Job Responsibility
  • Conducts intake/triage and appropriate classification of Clinical A&G, and Pharmacy requests and makes accurate judgment on appeal, grievance, Provider Claim Disputes, medical records or other issues and follows procedures on how to handle each type of request and route to the appropriate area within the department
  • Investigation, and resolution of clinical member complaints (grievances/appeals) utilizing all regulatory requirements
  • Investigation, and resolution of clinical Provider Complaints/ Provider Data Resolution (PDR) (grievances/appeals) utilizing regulatory and internal guidelines and Service Level Agreement (SLA)
  • Identification of Expedited Cases and resolution within 72 hours
  • Works with the external providers and Participating Physician Group's (PPG) representatives to obtain relevant medical records and communication documentation
  • Prepares resolved complaint files for Centers for Medicare and Medicaid Services (CMS), DMHC, and external review organization (QIO or IRE)
  • Process the case thru to effectuation and final case documentation in the A&G system of record
  • Investigation and preparation of State Fair Hearing cases as assigned
  • Prepares resolved complaint files for CMS external review organization - Quality Improvement Organization (QIO) or Independent Review Entity (IRE)
  • Conducts reviews and presents to physicians, provider disputes which would be based on medical necessity reviews
What we offer
What we offer
  • Paid Time Off (PTO)
  • Tuition Reimbursement
  • Retirement Plans
  • Medical, Dental and Vision
  • Wellness Program
  • Volunteer Time Off (VTO)
  • Fulltime
Read More
Arrow Right