Medical Writer in Costello Medical's Medical Communications team specializing in scientific publications and communication of clinical trial data. Collaborating with clients to deliver high - quality scientific materials.
About the role
- Clinical Writer preparing regulatory and clinical documentation for innovative medical devices at Withings. Collaborating with technical teams and ensuring compliance with medical regulations.
Responsibilities
- Draft clinical documentation for CE marking (Clinical Evaluation Plans and Reports) while establishing the link between clinical evaluation, risk management, post-market surveillance, etc.
- Collaborate closely with technical teams to gather relevant information and data from key stakeholders (physicians, clinical investigation personnel, regulatory affairs engineers, etc.) to ensure a thorough understanding of Withings devices and clinical outcomes.
- Serve as the clinical point of contact for communications with the Notified Body.
- Conduct systematic monitoring of the state of the art and similar devices for the intended applications.
- Draft, review, and maintain procedures and/or work instructions related to your role.
- Contribute to the management of the Post-Market Surveillance (PMS) process for the relevant Withings devices: drafting Post-Market Clinical Follow-up (PMCF) plans and reports, Post-Market Surveillance plans, PSURs, etc.
Requirements
- Degree from an engineering school or a scientific doctorate (PhD) or equivalent.
- Proven initial experience in medical regulatory affairs is essential.
- Strong knowledge of medical device regulations: MDR 2017/745, IVDR 2017/746, MEDDEV 2.7/1 rev 4, 510(k).
- Familiarity with ISO 13485 and ISO 14155 standards.
- Rigour, autonomy and strong organizational skills.
- Excellent written and verbal communication skills in French and English.
- Pragmatic, solution-oriented approach when addressing requests from regulatory authorities.
Benefits
- Joining Withings means:
- Join one of the pioneers and global leaders in connected health, a multiple-time award winner at the Consumer Electronics Show (CES).
- Contribute to innovative and ambitious projects for the health of tomorrow in an agile and constantly evolving environment.
- Join an international company, member of the French Tech 120, with teams based in Issy‑les‑Moulineaux, Boston, Hong Kong and Shenzhen.
- Participate in the continuous improvement of our products and services by beta-testing them before release, notably during our many colleague sports sessions.
- Benefit from numerous perks: stock options, smartphone and laptop of your choice, discounts for cultural and sports activities, company restaurant, and much more.
- Take part in the Withings Med Academy by attending healthcare professional conferences to strengthen your medical knowledge.
- Collaborate with passionate colleagues and celebrate each of our achievements together!
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