Regulatory Specialist Job at Edgerton Dental Clinic (Kraków)

Regulatory Specialist

Regulatory Specialist (East Windsor, NJ) (Multiple Openings).

Location

United States , East Windsor

Salary:

Not provided

Novitium Pharma

Expiration Date

Until further notice

Requirements

Must have bachelors in Pharmaceutical sciences / biology / microbiology / chemistry / chemical / Regulatory Affairs / Related + 1 year exp. as Regulatory Specialist /Quality Control Analyst / Chemist / Analyst / Scientist/ Research Associate / Related

Job Responsibility

Review, manage and write regulatory submissions electronically which include New ANDA filings, Complete Response letters, Information requests, Amendments to the ANDA’s (Labeling, Chemistry & Bioequivalence) of different dosage forms (Tablet, Capsule, Liquid & Solutions)
responsible for filing the Post Approval Supplements like CBE-0, CBE-30 (Changes being effective in 30 days) and Prior Approval Supplements (PAS)
submitting dossiers electronically after the approval of initial product submissions (ANDA)
review of the leachable and extractable reports generated for the oral Liquid & Solution drug products

Regulatory Specialist

At 2San, we are at the forefront of innovation in the global healthcare industry...

Location

United States , Norwood

Salary:

80000.00 USD / Year

2San

Expiration Date

Until further notice

Requirements

Proven regulatory affairs experience within the healthcare sector, with a focus on Class 2 and Class 3 Self-Test IVDs
Deep understanding of regulatory requirements and processes for the US market, including 510(k) management, FDA submissions, and compliance management
Experience with developing, implementing, and managing Quality Management Systems (QMS) in accordance with US and international standards, including familiarity with ISO 13485
Ability to develop and implement regulatory strategies that align with company objectives and product lifecycle
Strong analytical skills for assessing regulatory compliance, interpreting guidelines, and resolving complex issues
Excellent written and verbal communication skills for effective liaising with regulatory bodies, internal teams, and external partners
Proactive in identifying potential regulatory obstacles and developing effective solutions
Meticulous attention to detail with the capability to manage multiple projects and priorities simultaneously
Bachelor’s degree in a relevant scientific discipline (e.g., Biology, Chemistry, Biomedical Engineering) required
advanced degrees or certifications in regulatory affairs or quality assurance preferred

Job Responsibility

Monitoring and management of new and existing 510(k) entries to ensure all product listings are current and compliant with regulatory requirements
Preparing and submitting FDA applications for new product approvals and amendments for existing products, ensuring all submissions are accurate and meet regulatory standards
Maintaining the regulatory tracker to ensure all information is current and in-line with local requirements
Maintaining regular contact with manufacturers for products supplier in US. Ensuring that their conformity assessment is not due to lapse and ensuring that a plan is in place for updated certification. (IVDD to IVDR)
Regularly reviewing and updating the Quality Management System (QMS) to ensure it aligns with both US and international standards, including ISO 13485, and addressing any gaps or non-compliances
Overseeing Complaints Management and Post-Market Surveillance Activities, including the collection, analysis, and reporting of customer feedback and adverse events to regulatory bodies as required. Implementing corrective actions and ensuring continuous product quality and safety monitoring in compliance with regulatory requirements
Collaborating with product development teams to provide regulatory guidance and support from concept through to commercialization, ensuring regulatory considerations are integrated into product lifecycle management
Navigating regulatory pathways to secure product approval and market entry, including strategizing for efficient and compliant product launches
Applying strong analytical skills to assess regulatory compliance, interpret complex regulatory guidelines, and undertake risk assessments for regulatory strategies and submissions
Proactively identifying potential regulatory challenges and obstacles and working collaboratively with cross-functional teams to develop and implement effective solutions

Regulatory Affairs Specialist

Hemostasis, LLC designs, develops, manufactures, and markets advanced hemostat, ...

Location

United States , Saint Paul

Salary:

Not provided

Hemostasis Corp

Expiration Date

Until further notice

Requirements

Master’s degree in Regulatory Affairs and Services
Excellent written and oral communication skills
Demonstrate proactive and strategic thinking and be able to handle change and ambiguity

Job Responsibility

Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, and clarification/follow-up of submissions under review
Provide technical review of data or reports that will be incorporated into regulatory submissions
Analyze validation test data to determine whether systems or processes have met validation criteria
Study product characteristics or customer requirements and confer with management to determine validation objectives and standards
Identify deviations from established product or process standards and provide recommendations for resolving deviations
Develop validation master plans, process flow diagrams, test cases, and standard operating procedures
Create, populate and maintain the database for tracking validation activities, test results and validation systems
Prepare, maintain, and review validation and compliance documentation such as engineering change notices, schematics, and technical files to obtain and sustain product approval
Conduct audits of validation or performance qualification processes to ensure compliance with internal or regulatory requirements
Prepare additional information or responses as requested by regulatory agencies

What we offer

401K
Dental
Life
Medical
Disability
Competitive salary and benefits package including health, life, retirement and related benefits

Fulltime

Non-Pharma Global Regulatory Affairs Specialist

The Global Regulatory Non-Pharma Specialist manages regulatory documentation and...

Location

Italy , Bologna

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

At least 5 years’ experience in Regulatory Affairs preferably within the food supplements, medical devices, and cosmetics sectors
Exposure to regulatory operations or documentation in EU and/or RoW markets or similar experiences is preferred
Advance degree in Life Sciences, Pharmacy, Chemistry, or a related field
Relevant certifications in Regulatory Affairs are considered a plus
Good knowledge of EU regulations for medical devices (MDR, MDD) and relevant legislation for food supplements and cosmetics
Strong attention to detail, time management and organizational skills
Willingness to learn and ability to work effectively in a team-based environment
Strong communication and interpersonal skills
Proficiency in Microsoft Office Suite and familiarity with document management systems
Fluent in English, both written and spoken

Job Responsibility

Contributing in a cross-functional team to provide the necessary regulatory input for the development of new projects
Support regulatory strategies by providing impact assessments
Collaborate actively with the Research & Development team to integrate regulatory requirements during the design and development of assigned products
Prepare, organize and submit regulatory documentation for submission and maintenance of dossiers for the projects assigned
Coordinate with local affiliates and global stakeholders to ensure submissions are aligned with timelines and business priorities
Manage multiple tasks in a fast-paced environment while keeping on task and to the company’s quality standards
Contribute to the preparation of regulatory project updates in internal meeting and governance committee providing regulatory input and flagging risks
Assist colleagues with administrative tasks
Execute defined regulatory tasks within scope and deadlines under the guidance of the Head
Review and validate commercial artwork, packaging, and labeling in compliance with EU Regulations, ensuring timely product launches

What we offer

Competitive salary
Comprehensive benefits
Extensive opportunities for professional growth and development

Regulatory Reporting Specialist

The candidate will be in charge of preparing and submitting regulatory reports t...

Location

Italy , Rome

Salary:

Not provided

Aegis FSI

Expiration Date

Until further notice

Requirements

Degree-qualified with a strong track record (3+ years) in regulatory reporting in the financial services industry
In-depth knowledge and proven experience with European banking prudential regulations
Fluent English language skills, both written and spoken
Ability to perform accurately and efficiently under pressure and meet tight deadlines
Strong analytical skills with the ability to accurately identify, evaluate, and manage regulatory requirements

Job Responsibility

Lead the analysis and interpretation of prudential regulatory requirements from the Bank of Italy and EU, ensuring compliance and alignment with internal policies
Develop and implement strategic reporting solutions, while supporting group-level regulatory reporting in close collaboration with the Shared Services Regulatory Reporting Team
Evaluate the regulatory implications of new business initiatives and evolving prudential regulations (e.g. Basel 3+)
Contribute to effective regulatory change management by promoting cross-functional understanding and supporting the design and coordination of consistent implementation plans
Drive the financial planning and execution of high-impact strategic and regulatory projects
Contribute to the preparation and delivery of ICAAP documentation and Pillar 3 reports in line with regulatory expectations
Act as the primary point of contact for the external regulatory service provider, ensuring effective collaboration and service delivery

Junior Regulatory Affairs Specialist

Junior Regulatory Affairs Specialist of Cosmo Intelligent Medical Devices.

Location

Italy , Rome

Salary:

Not provided

Cosmo Intelligent Medical Devices

Expiration Date

Until further notice

Requirements

Bachelor’s degree in engineering, science or related scientific discipline, or equivalent
Minimum of 2 years of experience in regulatory affairs roles within the medical devices or healthcare industry
English proficiency at professional level
Professional knowledge of Reg. (EU) 2017/745 and Title 21 CFR parts 800-898 and technical standards ISO 13485, ISO 14971
Practical understanding of scientific and technological aspects related to software, computer engineering, artificial intelligence, and endoscopy
Strong analytical skills with a detail-oriented approach
Ability to work independently and collaboratively across multifunctional teams
Highly dynamic and adaptable to a fast-moving and innovative environment

Job Responsibility

Assess, prepare, and manage technical documentation to support certification and submission processes in the European Union and U.S.A
Prepare and manage technical dossiers for submission in other countries according to local regulations and guidance documents
Cooperate with other departments to the creation and update of technical documentation needed according to country requirements
Assist external stakeholders in the regulatory process per country requirements
Maintain and update certifications, registrations, and renewals as required by country regulations and assess regulatory impact of medical device changes with respect to country requirements
Cooperate to the management of documented material and communications with Competent Authorities, Certification Bodies, and other stakeholders according to the given regulatory aspect
Cooperate to the management of company regulatory procedures by timely awareness and implementation of changes due to the development in the regulatory landscape
Assist in internal and external audits and provide regulatory input to optimize company compliance and minimize the possibility of non-compliance findings
Promote the culture of compliance by proactively interacting with all departments and by provision of trainings
Cooperate to the development of new activities, adapt to new challenges and opportunities, and take on new duties stemming from the development path of company activities

Energy Agreements & Compliance Specialist

Energy Agreements & Compliance Specialist to join the Long-term Optimization tea...

Location

Greece , Athens

Salary:

Not provided

Metlen Group

Expiration Date

Until further notice

Requirements

Bachelor's degree in Engineering, Law, Economics
Master's degree in Energy Law, Energy Markets, or Regulation are an asset
4+ years of experience in energy contract management, regulatory compliance, market operations, or energy economics
Strong understanding of EU/Greek regulatory frameworks (REMIT, EMIR, MAR, NRA decisions, DAPEEP rulebooks, Balancing Regulation)
Knowledge of regional market frameworks (Balkan region) is considered a plus
High attention to detail, structured thinking, and ability to manage multiple priorities
Proficient in MS Office, especially Word
Proficiency in English (written & spoken) and fluency in Greek

Job Responsibility

Draft Renewable Energy PPAs and BESS Optimization Agreements
Prepare, review, and maintain standard and bespoke agreements for energy trading and aggregation activities
Take full ownership of the agreements process
Collaborate with Legal, Risk, and Market Operations teams
Develop and maintain internal compliance procedures, checklists, and reporting documentation
Monitor EU and Greek regulatory developments
Ensure compliance with REMIT, EMIR, and relevant market frameworks
Support the development and maintenance of strong relationships with key clients and partners

What we offer

Competitive remuneration package
Ticket Restaurant Card
Group Health Insurance Plan
Preferential household electricity plan
Pension Plan

Fulltime

Statutory Reporting System Implementation Specialist

The Statutory Reporting team operates as an independent group of subject matter ...

Location

Hungary , Budapest

Salary:

Not provided

Citi

Expiration Date

Until further notice

Requirements

University/College degree in Finance, Accounting or Economics
Minimum of 3 years of experience in financial auditing (internal or external) or financial reporting and accounting or controlling
IFRS experience
IT affinity
Experience with structured data manipulation or scripting logic is highly desirable
Proactive work ethic with strong capabilities in time and issue management
Accuracy and attention to detail
Planning and organizational skills, able to prioritize work
Advanced verbal and written communication skills in English

Job Responsibility

Contributing to the overall project objectives of a small team responsible for implementing Workiva
Become an SME on Workiva software capabilities and customization
Participate in the development and implementation project of migrating CSC owned financial statements to Workiva
Advise and provide expertise to country finance teams on best practice solutions

What we offer

Cafeteria Program
Home Office Allowance
Paid Parental Leave Program
Private Medical Care Program
Pension Plan Contribution
Group Life Insurance
Employee Assistance Program
Access to learning and development programs
Flexible work arrangements
Career progression opportunities

Fulltime

Regulatory Specialist

Edgerton Dental Clinic

Location:
Poland , Kraków

Category:
-

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
April 02, 2026

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Regulatory Specialist

Edgerton Dental Clinic

Location:Poland , Kraków

Category:-

Contract Type:Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:April 02, 2026

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Location:
Poland , Kraków

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Contract Type:
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Job Posted:
April 02, 2026