Senior Regulatory Affairs

il y a 3 semaines

Paris, Île-de-France EPM Scientific Temps plein

Job Title: Senior Regulatory Affairs Specialist

Location: France (Hybrid)

Start Date: Within the next month

Job Type: Full-time (Consultant, Freelancer, or Contractor)

Industry: Medical Devices

Key Responsibilities:

  • Documentation Specialist: Lead and manage all regulatory documentation processes, ensuring compliance with local and international regulations.
  • Regulatory Submissions: Prepare and submit regulatory filings to relevant authorities, including CE marking, FDA submissions, and other global regulatory requirements.
  • Quality Team Collaboration: Work closely with the quality team to ensure all regulatory requirements are met and maintained throughout the product lifecycle.
  • Project Support: Provide regulatory support for ongoing projects, ensuring timely and compliant product development and market entry.
  • Compliance Monitoring: Stay updated with regulatory changes and ensure the company's products and processes comply with current regulations.
  • Risk Management: Identify and mitigate regulatory risks associated with product development and market entry.
  • Training and Mentorship: Provide training and mentorship to junior regulatory affairs staff and other team members.

Qualifications:

  • Experience: Proven experience as a consultant, freelancer, or contractor in regulatory affairs within the medical device industry or own company set up.
  • Knowledge: In-depth knowledge of regulatory requirements and standards for medical devices, including ISO 13485, MDR, and FDA regulations.
  • Skills: Excellent documentation and communication skills, strong attention to detail, and the ability to work collaboratively in a hybrid work environment.
  • Languages: Proficiency in English and French is preferred.

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