Withings

Medical Writer – M/F

Withings

full-time

Posted on:

Location Type: Hybrid

Location: Issy-les-Moulineaux • France

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About the role

  • Draft clinical documentation for CE marking (Clinical Evaluation Plans and Clinical Evaluation Reports), ensuring alignment between clinical evaluation, risk management, post-market surveillance (PMS), and related activities.
  • 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 surveillance of the state of the art and comparable devices for the intended applications.
  • Draft, review, and maintain procedures and/or work instructions related to the 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, Periodic Safety Update Reports (PSURs), etc.

Requirements

  • Degree from an engineering school or a scientific doctorate (PhD) or equivalent.
  • Proven initial experience in medical regulatory affairs is required.
  • 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 mindset when responding to requests from market authorization authorities.
Benefits
  • Joining Withings means:
  • Becoming part of a pioneer and global leader in connected health, multiple award-winner at the Consumer Electronics Show (CES).
  • Contributing to ambitious, innovative projects shaping the future of health in an agile, fast-evolving environment.
  • Joining an international company, member of the French Tech 120, with teams based in Issy-les-Moulineaux, Boston, Hong Kong, and Shenzhen.
  • Participating in continuous product and service improvement by beta-testing releases, including during our many colleague sports sessions.
  • Enjoying a range of benefits: stock options, a smartphone and laptop of your choice, discounts for cultural and sports activities, company restaurant, and much more.
  • Attending Withings Med Academy sessions and conferences led by healthcare professionals to deepen your medical knowledge.
  • Collaborating with passionate colleagues and celebrating our successes together!
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
clinical documentationclinical evaluation plansclinical evaluation reportspost-market surveillancerisk managementmedical regulatory affairsMDR 2017/745IVDR 2017/746MEDDEV 2.7/1 rev 4510(k)
Soft Skills
rigourautonomyorganizational skillswritten communicationverbal communicationpragmatic mindsetsolution-oriented mindset
Certifications
PhD