Ra Specialist Job at Product Life Group

New

Senior QARA Specialist

This is where your work makes a difference. At Baxter, we believe every person—r...

Location

Algeria , Algiers

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Responsible for QA and RA communications with health authorities
Will be the nominated pharmacist in charge for Baxter's operating establishment
Will be the authorized signatory entity & official responsible pharmacist for all PVQARA communications
Will be nominated as Baxter's point of contact for all RA & QA activities in front of MOH
Assume the tasks of the Responsible Pharmacist of Baxter entity in Algeria as defined by the local regulations
Ensure company compliance with applicable Acts and regulations, and cGMP, in the control of medicines and medical devices distributed and sold by Baxter Healthcare
Prepare for MOH audits and ensure satisfactory outcomes
To keep awareness and being updated on relevant national Algerian and assigned countries’ legislation and inform ECEMEA cluster head and global teams about any relevant changes to the legislation
To ensure that CQA processes are in place in his / her region: Local Complaint Coordinator activity, Product Surveillance activity for Medicinal Products and Medical Devices, Field Action execution, Supplier & Distributor Management, Implementation of Baxter Quality System in the region and audit management, NCR, CAPA and Change Management, Selling Authorizations and release of products according to local requirements
Ensure back up persons for critical processes in the region are appropriately trained and back up are always available

Job Responsibility

Responsible for QA and RA communications with health authorities
Will be the nominated pharmacist in charge for Baxter's operating establishment
Will be the authorized signatory entity & official responsible pharmacist for all PVQARA communications
Will be nominated as Baxter's point of contact for all RA & QA activities in front of MOH
Assume the tasks of the Responsible Pharmacist of Baxter entity in Algeria as defined by the local regulations
Ensure company compliance with applicable Acts and regulations, and cGMP, in the control of medicines and medical devices distributed and sold by Baxter Healthcare
Prepare for MOH audits and ensure satisfactory outcomes
To keep awareness and being updated on relevant national Algerian and assigned countries’ legislation and inform ECEMEA cluster head and global teams about any relevant changes to the legislation
To ensure that CQA processes are in place in his / her region: Local Complaint Coordinator activity, Product Surveillance activity for Medicinal Products and Medical Devices, Field Action execution, Supplier & Distributor Management, Implementation of Baxter Quality System in the region and audit management, NCR, CAPA and Change Management, Selling Authorizations and release of products according to local requirements
Ensure back up persons for critical processes in the region are appropriately trained and back up are always available

Fulltime

New

Senior QARA Specialist

This is where your work makes a difference. At Baxter, we believe every person—r...

Location

Algeria , Algiers

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Responsible for QA and RA communications with health authorities
Will be the nominated pharmacist in charge for Baxter's operating establishment
Will be the authorized signatory entity & official responsible pharmacist for all PVQARA communications
Will be nominated as Baxter's point of contact for all RA & QA activities in front of MOH
Assume the tasks of the Responsible Pharmacist of Baxter entity in Algeria as defined by the local regulations
Ensure company compliance with applicable Acts and regulations, and cGMP, in the control of medicines and medical devices distributed and sold by Baxter Healthcare
Prepare for MOH audits and ensure satisfactory outcomes
To keep awareness and being updated on relevant national Algerian and assigned countries’ legislation and inform ECEMEA cluster head and global teams about any relevant changes to the legislation
To ensure that CQA processes are in place in his / her region
To ensure that RA processes are in place in his / her region

Job Responsibility

Local Complaint Coordinator activity
Product Surveillance activity for Medicinal Products and Medical Devices
Field Action execution
Supplier & Distributor Management
Implementation of Baxter Quality System in the region and audit management
NCR, CAPA and Change Management
Selling Authorizations and release of products according to local requirements
Ensure back up persons for critical processes in the region are appropriately trained and back up are always available
To ensure that processes and procedure related to mentioned activities are compliant to local regulations, to the Corporate Quality Manual and to ISO 9001 and 13485 requirements.

Regulatory Affairs Specialist

Join a top-tier global healthcare leader with a stable, inclusive, and professio...

Location

Japan , Tokyo

Salary:

4000000.00 - 8000000.00 JPY / Year

Randstad

Expiration Date

November 30, 2026

Requirements

Strong English and Japanese communication skills (written and verbal)
Experience in Regulatory Affairs for IVD or Medical Devices
typically 2+ years preferred, but equivalent experience considered
Ability to collaborate effectively with cross-functional teams
Understanding of regulatory requirements for IVD/Medical Devices
Basic understanding of ISO 13485 and global QMS principles
High attention to detail and strong documentation management skills

Job Responsibility

Work as a Legal Manufacturer RA, driving global market access directly from Japan
Engage in cross-border projects using English daily within a dynamic factory RA team

What we offer

健康保険
厚生年金保険
雇用保険
土曜日
日曜日
祝日

Fulltime

Regulatory Affairs Specialist

We are seeking a highly skilled Regulatory Affairs Specialist with 4–6 years of ...

Location

United States , Minneapolis, Plymouth

Salary:

Not provided

Amaris Consulting

Expiration Date

Until further notice

Requirements

5+ years of Regulatory Affairs experience within the medical device industry
Strong knowledge of international registration and renewal processes (APAC and LATAM preferred)
Practical experience with regulatory document structures: Design History File (DHF), Device Master Record (DMR), Device History Record (DHR), EU Technical Documentation
Experience using document management systems (Windchill highly preferred)
Familiarity with Certificate to Foreign Government (CFG) requirements
Excellent organizational, analytical, and communication skills
Ability to work independently with minimal supervision
Must be located in the United States
Availability for occasional evening calls to accommodate APAC time zones

Job Responsibility

Interface with regional Market RA teams to gather and interpret country-specific regulatory requirements
Retrieve, review, and assemble documentation from DHF, DMR, DHR, and EU Technical Files
Navigate document management systems (Windchill preferred) to locate, verify, and extract required documents
Prepare submission packages following country-specific templates and regulatory guidelines
Maintain and update Excel dashboards to track deliverables, timelines, and submission progress
Coordinate document transfers (email/SharePoint) with regional RA teams
Provide daily progress and status updates to project leadership
Support coordination of notarizations and translation activities (no execution required)
Ensure compliance with international regulatory standards, including CFG requirements

What we offer

An international community bringing together more than 110 different nationalities
An environment where trust is central: 70% of our leaders started their careers at the entry level
A strong training system with our internal Academy and more than 250 modules available
A dynamic work environment that frequently comes together for internal events (afterworks, team buildings, etc.)

Fulltime

Senior Regulatory Affairs Specialist

New RA position dedicated to the Reusable Pen Platform and its 2 strategic custo...

Location

United States , Franklin Lakes

Salary:

59.00 - 63.00 USD / Hour

MillenniumSoft Inc

Expiration Date

Until further notice

Requirements

Minimum of 5 years of directly related work experience in medical device regulatory field (regulatory submissions, compliance, project management)
Medical device and international registration experience is a must
Proficient in using Microsoft Word, Access, Excel, OneNote, Project, and OneDrive/SharePoint
Strong project management and communication (verbal, written) and skills
Able to independently handle multiple tasks/projects with minimum supervision
Self-starter with the ability to take over responsibilities
Team player, Attention to details, Highly result-oriented
Flexible and reliable personality
ability to manage stressful situations
High personal integrity and ethical standards

Job Responsibility

Ensure timely execution of regulatory strategies and customer deliverables as determined by RA Manager
Manage and execute end to end activities, such as documentations, submissions and addressing health authority questions for new or renewal of existing medical device registrations of Reusable Pen and pen needles in worldwide market
Maintenance of compliant regulatory files and supporting documentation (EU technical files/ US master files/international technical dossiers) in WW market
Performs regulatory impact assessment of changes related to design, improvements and customer experience and coordination of supplement/notification/change submissions for timely implementation
Effective Collaboration with multiple stakeholders i.e. internal teams (PS cross functional, BDX), customers (consultants, pharma partners) and regulators (EU Notified Body, Health Canada, FDA) for technical requirements and documentation to support regulatory registrations, project deliverables and audit ready folders
Manages multiple projects with attention to detail for health authority submissions and represent RA in internal and external audits by customers and health authorities for compliance to MDSAP, EUMDR, ISO 13485 and global compliance
Identify ways to improve the efficiency of current work process and best practices as necessary.

What we offer

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture and life balance components — is designed to support the varying needs of our diverse associates.

Fulltime

Regulatory Affairs Specialist II

On behalf of our client, a leading manufacturer and seller of products for the l...

Location

United States , Irvine

Salary:

45.00 - 50.00 USD / Hour

Tucker Parker Smith Group

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Biochemistry, Biology, Medical Technology, or a related field
3–5 years of experience in Regulatory Affairs, Quality Assurance, R&D, Manufacturing, or Project Management within the IVD industry
Knowledge of FDA and CE marking requirements for IVD products strongly preferred
Strong ability to work both independently and in a collaborative environment
Excellent communication skills, with the ability to negotiate and persuade effectively
Proven analytical, problem-solving, critical thinking, and computer skills
In-depth understanding of Regulatory Affairs policies, practices, and procedures

Job Responsibility

Revise assigned technical files using the latest templates to ensure clarity and compliance with IVDR requirements, including incorporation of technical reports, validations, and test data
Meet pre-defined timelines and actively participate in multiple weekly meetings to address issues, answer questions, and provide progress updates to the project manager
Support the IVDR labeling conversion project by updating specifications, tracking logs, and collaborating cross-functionally to ensure compliance
Monitor monthly manufacturing schedules, product fill dates, lot numbers, and change requests for accurate labeling updates
Manage un-CE Marking of selected products and track changes until final labeling reflects updated specifications
Maintain technical file tracking logs and notify regional RA teams of labeling changes
Coordinate with the RA SAP restriction coordinator to restrict specific product lots when required

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

Regulatory Specialist

Join our Regulatory Affairs team and play a key role in ensuring compliance and ...

Location

Poland , Kraków

Salary:

Not provided

Edgerton Dental Clinic

Expiration Date

Until further notice

Requirements

College degree in a related technical discipline with 5+ years of professional experience
Direct experience in Dangerous Good regulations (as ADR, IMDG, IATA, other)
Good problem-solving skills
Strong written and verbal communication skills
Excellent interpersonal and communication skills and a proactive, self-motivated approach, collaborative mindset and positive attitude
Proficiency in Excel and familiarity with AI tools are considered assets

Job Responsibility

Manage small to medium projects representing in Dangerous Good area
Independently prepares, coordinates and secures all necessary permits, documentation needed for regulatory compliance
Ensures compliance with existing Dangerous Good laws, regulations, permits pertaining to health, safety and environmental control
Creates business value and competitive advantage through broad regulatory knowledge
Support supervisor or other regulatory personnel with special projects
Monitor regulation changes to ensure continued compliance
Maintain and share knowledge
May represent the RA department in project team meetings

What we offer

Attractive salary (Base pay & Variable Plan) and benefits package (private medical care, life insurance, stock purchase, lunch subsidy, sport cards)
Flexible working arrangements with hybrid model of work (approx. 60% from the office and 40% from home)
Thrive in our matrix organization, working across Europe with various teams and cultural backgrounds
Strong teamwork and diverse interactions
Personalized plans with rapid progression
Professional growth supported by active committee for different career levels
High employee satisfaction and responsive feedback
Continuous learning and technical training incl. subject matter experts’ training, soft skills and management training and LinkedIn learning
Assistance for international candidates and candidates living outside of Krakow
Social events such as family events and charity auctions

Fulltime

Ra Specialist

Product Life Group

Location:
Australia

Category:
Consulting

Contract Type:
Not provided

Salary:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
April 16, 2026

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