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Regulatory & Compliance Project Manager

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Nemera

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Location:
France , Lyon

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Category:
IT - Administration

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Contract Type:
Employment contract

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Salary:

Not provided
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Job Description:

Within Nemera’s headquarters, you will lead the regulatory & compliance design projects of drug delivery devices. You will report to the Regulatory Affairs Manager of the BU and you will work closely with the development team, from requirements through to design, development, industrialisation, post marketing, quality, covering all aspects from defining regulatory strategies, and supporting quality management plans through to QMS development and process improvement.

Job Responsibility:

  • Lead the regulatory & compliance design projects of drug delivery devices
  • Collaborate with development teams and with the production site(s) to ensure correct implementation of regulatory and normative activities
  • Be in charge of the resources assessment needed for regulatory and normative activities
  • Collaborate with different teams to contribute to the continuous improvement processes
  • Prepare, verify, approve, submit regulatory documents and collect normative information needed for submission
  • Participate in the drafting, verifying and approving plans and verification reports
  • Contribute and assist to internal or external audits and propose corrective and preventive actions
  • Collect and interpret elements of the monitored standards, inform product or process managers for the changes, analyze and synthesize gaps
  • Summarize regulatory and/or normative requirements
  • Support Insight teams during product-specific normative interactions with external stakeholders
  • Participate in standardization committees and external expert groups
  • Conduct in-depth analyzes of proposed product changes, assessing their impact, evaluating the normative compliance and proposing corrective measures

Requirements:

  • Engineering degree or equivalent
  • At least 5 years professional experience
  • Background in pharmaceutical or biomedical industry in multicultural and interdisciplinary environment
  • Knowledge and experience in eCTD (Electronic Common Technical Document) Module 3 CMC, CE certification, Notified Body Opinion process
  • Experience in leading Regulatory & Compliance projects in transversal projects
  • Experience in quality management system and GMP
  • Knowledge of 21 CFR part 820, ISO 13485, MDR2017/745, ISO 14971
  • Good English speaking and written

Nice to have:

  • Knowledge of ISO 11608 and ISO 23908 are optional
  • Knowledge of the process of medical device design

Additional Information:

Job Posted:
February 18, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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