Senior Regulatory Affairs - Documentation Specialist

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.