Regulatory Affairs & Quality Assurance

Key Responsibilities

• Develop and execute regulatory strategies for product submissions and approvals, ensuring compliance with applicable regulations like EU-IVDR.
• Prepare and maintain the technical files according to EU-IVDR / STED
• Maintain company and product critical data in applicable EUDAMED databases
• [Future]: prepare and submit regulatory filings, CE marking applications, and technical files.
• Serve as the primary point of contact for regulatory bodies, notified bodies and ensure timely communication and submissions [as applicable].
• Monitor changes in global regulatory requirements and assess their impact on the company’s products and processes.
• Provide regulatory guidance during product development and change management to ensure compliance from concept to commercialization.
• Vigilance management: reporting of complaints and adverse events to the Competent Authority

• Develop, implement, and maintain Quality Management Systems (QMS) in compliance with applicable standards ISO 13485 and EU-IVDR.
• Auditing:
• Plan, perform, report and organize follow-up of internal audits
• Lead the preparation for and host /support external audits and inspections and their internal follow-up.
• Create, review, and manage documentation, including Standard Operating Procedures (SOPs), work instructions, and quality records.
• Monitor and manage CAPAs, non-conformances, and deviations.
• Ensure the establishment and maintenance of robust supplier and vendor qualification processes.
• Lead the change management process to assure compliant and effective changes of QMS, products and their files / registrations.
• Conduct training sessions to promote a culture of quality across the organization and to have qualified staff for activities covered by the QMS.
• Manufacturing Quality support:
• Provide structure and guidance to records management for manufacturing (like batch record management)
• Execute final release activities to assure release of compliant products and services to customers
• Records management: archiving and maintenance of QMS / quality records

• Collaborate with cross-functional teams, including R&D to establish and maintain design controls throughout the product lifecycle.
• Support the creation and review of Design History Files / technical files and associated documentation, ensuring compliance with design control requirements.
• Oversee risk management activities in accordance with ISO 14971, including hazard analysis, risk evaluation, and risk mitigation.
• Provide guidance and hands-on support for verification and validation activities, including test method development and validation, process validation, and design validation.
• Ensure traceability from user needs and design inputs through to design outputs and validation.
• Participate in design reviews, providing quality and regulatory input to ensure products meet both customer and regulatory requirements.
• Provide quality support to Design Control activities

• Complaint management
• Vigilance management (see RA)
• Execution and/or support to of internal processes for PMS: clinical evaluations, mandatory EU reporting [as applicable]

Qualifications and Experience

• Bachelor’s degree in Life Sciences, Engineering, or a related field; advanced degree is a plus.
• 3–5 years of experience in Quality Assurance and/or Regulatory Affairs, ideally within the Life Sciences, medical devices, or biotech sectors.
• Strong knowledge of QMS standards (ISO 13485, FDA 21 CFR Part 820) and regulatory requirements (EU MDR, FDA QSR).
• Proven ability to prepare and manage technical files. Plus / future: regulatory submissions (e.g. CE marking).
• Experience with hands-on implementation of quality systems and documentation in a small company or start-up environment.
• Excellent communication, organizational, and problem-solving skills.
• Ability to work independently and collaboratively in a fast-paced, resource-constrained environment.

Key Competencies

• Hands-On Approach: Willingness to manage day-to-day tasks, from high-level strategy to detailed execution.
• Adaptability: Thrives in a start-up environment with shifting priorities and limited resources.
• Detail-Oriented: Strong focus on accuracy and precision, especially in regulatory documentation and quality records.
• Proactive Problem-Solving: Ability to anticipate challenges and implement effective solutions.
• Collaboration: Strong interpersonal skills to work closely with cross-functional teams.

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