Regulatory Affairs Officer

il y a 2 jours

Lyon, Auvergne-Rhône-Alpes, France Astek Temps plein

What We Will Accomplish Together
Alsinova
, a
subsidiary of the Astek Group
, is a consulting firm specialized in
Life Sciences
. We support pharmaceutical, biotech, and medtech companies by providing high-level expertise in
regulatory affairs, clinical development, data, quality, and pharmacovigilance
. To support one of our major partners in the
in vitro diagnostics (IVD)
sector, we are currently looking for a
Regulatory Affairs Officer
with proven experience in
IVDR compliance
and medical devices.

Your Mission (should You Decide To Accept It)
As a
Regulatory Affairs Officer
, you will contribute to ensuring that the company's IVD products remain compliant with the evolving
IVDR regulations
and other applicable standards.

Your Daily Activities Will Be

  • Support regulatory activities related to CE marking under IVDR
  • Prepare, review, and update technical documentation (TD) for IVD products in accordance with IVDR Annex II & III
  • Ensure compliance of labeling, Instructions for Use (IFU), and claims with IVDR and applicable national regulations
  • Participate in gap assessments, risk management documentation, and post-market surveillance strategies
  • Contribute to interactions with notified bodies or regulatory authorities as needed
  • Collaborate cross-functionally with QA, R&D, Clinical, and Marketing teams

You

  • Higher education in Life Sciences, Regulatory Affairs, or related field.
  • 2–5 years of experience in regulatory affairs for medical devices or IVDs.
  • Solid understanding of EU Regulation 2017/746 (IVDR) and related guidance.
  • Experience with technical documentation, CE marking, and notified body submissions.
  • Knowledge of ISO 13485, risk management (ISO 14971), and post-market requirements.
  • Proactive, detail-oriented, and able to work independently in a dynamic environment.
  • Strong writing and communication skills in English.
  • French is a plus.

Our Experience
Joining Astek means choosing:

  • an experience accelerator, where every assignment is an opportunity to progress
  • access to a multitude of technically exciting projects for our clients as well as internally
  • individualized, local support for a tailored career path
  • continuous learning, thanks to our internal training academy
  • a friendly and inclusive work environment, supported by #TopEmployer2025 certified HR practices Let's move forward.

We Base Our Relationships On

  • Respect for employees and clients, and their aspirations,
  • Personalized support for employees and clients,
  • Regular career management,
  • Transparent communication,
  • Constant responsiveness, availability, and attentiveness.

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