Regulatory Affairs Specialist Job at MillenniumSoft Inc (Tempe)

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 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

Senior Regulatory Affairs Specialist

Senior 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 medicine, pharmacology, biomedical science or related scientific discipline, or equivalent
Minimum of 5 years of experience in the regulatory affairs field in medical device industry
Minimum of 2 years of experience in vigilance reporting according to 21 CFR Part 803 in U.S and to MDD/MDR requirements in EU
English proficiency at professional level
Deep knowledge and operative understanding of Reg. (EU) 2017/745 and MDCG documents, Title 21 CFR parts 800-898, and technical standards such as ISO 13485, ISO 14971, ISO/TR 20416, ISO 62304
Practical understanding of scientific and technological aspects related to software, computer engineering, artificial intelligence, and endoscopy
Basic knowledge of Reg. (EU) 2024/1689
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 medical device safety by providing input/review to the risk management activities throughout the whole product lifecycle, health hazards evaluations, and clinical evaluation reports
Review and provide input on mitigations, labeling and training materials, adverse events, complaints, incidents, and trends
Manage and document post-marketing safety data, aggregate complaint data, individual case safety reports, literature reports with safety data, trend analysis
Manage vigilance reporting to Competent Authorities and other stakeholders according to country requirements and assess failure investigations from the regulatory viewpoint
Work with customers/users to gather information/data to support investigations and complaints management
Monitor external sources/trends on emerging issues, including complaints, MDR trends, and regulatory trends, literature and scientific publications
Transfer the regulatory compliance aspects during the design and development stage of products and act as contact point across the company functional areas
Act as department representative during audits and other regulatory body interactions in the field of vigilance and post-market surveillance
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

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

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 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

Senior Regulatory Specialist

The Senior Regulatory Specialist is responsible for planning, managing, and impl...

Location

United States , Burnsville

Salary:

100000.00 - 130000.00 USD / Year

Imricor Medical Systems

Expiration Date

Until further notice

Requirements

Bachelor of Science in a scientific discipline or equivalent education/ training
5+ years’ Regulatory and/or Compliance-related experience in a regulated industry
Previous experience with US and EU medical device regulatory requirements including Quality Systems and clinical investigations standards
Experience with preparation, submission, and approval for medical devices is required
Strong communication skills, both verbal and written
Strong analytical and problem-solving skills, as well as a good background in the medical device development process
Demonstrated ability to effectively manage multiple projects and priorities
Skills in multiple computer-based tools and software such as Word, PowerPoint, Excel, and Adobe Acrobat

Job Responsibility

Develops domestic and international strategies for regulatory approval of company products
Coordinates, compiles, and submits U.S. and international regulatory filings for new and modified products, including PMAs, 510(k)s, IDEs, CE Marking submissions, and other country-specific product registrations
Develops and maintains positive relationships with regulatory body reviewers through oral and written communications regarding clarification and follow-up of submissions under review
Reviews product and manufacturing changes for compliance with applicable regulations and impact on regulatory filings
Represents RA on cross-functional product development, manufacturing, and clinical support teams and provides regulatory leadership and feedback throughout the product development cycle. Provides recommendations for how to overcome regulatory barriers
Provides technical reviews of supporting documentation for inclusion in regulatory filings
Supports Medical Device Reporting (MDRs) and Medical Device Vigilance Reporting
Represents RA on other cross-functional projects, which may include process changes and continuous improvement efforts
Meets defined goals and objectives through own initiatives, activities, and available resources with minimal supervision
Performs other related duties and responsibilities, as assigned

What we offer

Medical
Dental
Vision
Health Savings Accounts
Health Care & Dependent Care Flexible Spending Accounts
Disability Benefits
Life Insurance
Retirement Benefits

Fulltime

Namibia Public Affairs Specialist

You will join the Upstream business unit that develops a competitive and unique ...

Location

Namibia , Windhoek

Salary:

Not provided

Galp

Expiration Date

Until further notice

Requirements

A Namibian National with an established track record of successfully interacting with Namibian Governmental Departments and associated Government Owned Organisations and the wider Namibian general business sector
A passion for the energy industry and understanding of the value chain features, particularly related to upstream exploration and appraisal activity
A humble attitude, the ability to work within a team towards a common goal and be a respected company representative amongst stakeholders to build relationships in multi-cultural environments
Ideally 5+ years of experience in Energy Industry in Namibia or a country with a developed oil and gas sector
Willingness to help local communities and a pronounced social responsibility

Job Responsibility

Develop Galp´s Institutional representation with all relevant stakeholders as well as liase with Government Departments in all related industry issues
Active participation in the shaping of the Oil & Gas public policy environment and ecosystem enabling Galp Namibia to participate and deliver innovative solutions for country regulatory framework
Careful monitor of the changing political dynamics and government policies to identify emerging external challenges and opportunities to Galp, develop recommendations and mitigation actions
Assist in the implementation of the Company Social Responsibility strategy for Namibia
Liaise with Corporate Departments (Finance, Accounting, Tax,Procurement, People Team) to provide local support to any task deemed necessary

What we offer

An energy company integrated in the energy sector where you can make a difference
Challenging Projects
Competitive salary and bonus

Fulltime

Regulatory Affairs Specialist

MillenniumSoft Inc

Location:
United States , Tempe

Category:
IT - Administration

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
January 11, 2026

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