Senior Specialist in Regulatory Compliance

il y a 4 semaines


Paris, Île-de-France elemed Temps plein

Position: Senior Specialist in Regulatory Compliance

Location: Remote

About the Company

Our client, a leading French enterprise in the ophthalmic sector, excels in managing the entire production process, from the initial creation of raw materials to the final packaging of products. All offerings are CE certified, ensuring compliance with European standards.

Renowned for its innovative approach, our client is among the pioneers in the development and commercialization of hydrophobic lenses.

Role Overview

Are you prepared to elevate your career in the vibrant medical device industry? As a Senior Specialist in Regulatory Compliance, you will play a crucial role in safeguarding the safety and efficacy of advanced ophthalmic products. This position provides a distinctive opportunity to influence the future of ophthalmic medical devices while enjoying the flexibility of remote work.

Key Responsibilities:

  • Serve as a liaison and facilitator for Vigilance, Risk Management, Clinical, and Post-Market Surveillance (PMS) activities.
  • Gather and evaluate vigilance data for integration into PMS. Analyze post-market surveillance information to identify and report potential trends and risks.
  • Collaborate with Design, Clinical Affairs, and Quality teams to ensure consistent risk management practices.
  • Plan and oversee PMS initiatives, including the development of post-market surveillance strategies.
  • Act as a PMS expert in cross-functional projects and initiatives.
  • Educate and train internal teams on regulatory standards and post-market surveillance protocols.
  • Establish, monitor, and report on key performance indicators related to PMS activities.

Qualifications:

  • Proven experience in Post-Market Surveillance within the Medical Device industry.
  • Ability to work independently while promoting a collaborative team environment.
  • Exceptional communication, organizational, and writing skills in both French and English.

About Elemed

Elemed is the foremost technical recruiter in the MedTech sector across Europe, specializing in medical devices, diagnostics, and combination products. Our team is dedicated to assisting current medical device professionals in becoming future leaders.

Join Elemed's RQC Network to gain access to industry insights, expert-led masterclasses, and additional resources. Experience growth and mentorship from seasoned professionals in the medical device field.

We are committed to fostering diversity and equality within our organization, valuing all backgrounds and experiences.



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