Regulatory & Compliance Project Manager FMX

Regulatory & Compliance Project Manager F / M / X (CDI) – Based in Lyon (7e). Job Description We are looking for a unique person ready to make a difference and join our Compliance & Regulatory team as Regulatory & Compliance Project Manager based in Lyon. Within Nemeras 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 work closely with the development team from requirements through to design development, industrialisation and post‑marketing quality covering all aspects from defining regulatory strategies to supporting quality management plans and QMS development and process improvement. Responsibilities Collaborate with development teams and production sites to ensure correct implementation of regulatory and normative activities. Assume responsibility for resource assessment needed for regulatory and normative activities under ownership and product platform. Contribute to continuous improvement processes. Prepare, verify, approve, submit regulatory documents and collect normative information needed for submission to authorities, notified bodies or customers. Draft, verify and approve plans and verification reports from internal or external laboratories concerning products under ownership. Assist in internal or external audits and propose corrective and preventive actions. Collect and interpret monitored standard elements, inform product or process managers, analyze gaps, and collaborate with other departments to guarantee normative compliance. Summarize regulatory and/or normative requirements. Support Insight teams during product‑specific normative interactions with external stakeholders such as regulatory organisms and customers. Participate in standardization committees and external expert groups to understand, anticipate, and influence existing or new standards. Conduct in‑depth analyses of proposed product changes, assess impact, evaluate normative compliance, and propose corrective measures if necessary. Qualifications & 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 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. Optional knowledge of ISO 11608 and ISO 23908. Knowledge of the process of medical device design. Good English speaking and written. Occasional travel. Soft Skills Effective interpersonal skills; ability to work in a team or independently. Ability to multi‑task and manage priorities; strong organizational and time management skills. Demonstrated flexibility and adaptability. Highly motivated with a proactive approach to learning and problem solving. Analytical and synthetical skills. Competences Medical devices. MDR 2017 / 745. Generic drugs. Languages Fluent in English (company language). Diversity & Inclusion Nemera is an equal‑opportunity employer. We review all qualified applications, including those of people with disabilities. Diversity and inclusion is everyone's responsibility. Application Process CV Review. Initial Screening. Interview with Hiring Manager. Interview with N2. HR Manager Interview. Offer. Remote Work No. Employment Type Full‑time. #J-18808-Ljbffr