Regulatory & Compliance Project Manager F/M/X

Regulatory & Compliance Project Manager F/M/X

We are looking for a unique person ready to make a difference and join our Compliance & Regulatory team as Regulatory & Compliance Project Manager F/M/X, based in Lyon (7e).

Within Nemera’s headquarters, you will lead regulatory & compliance design projects of drug delivery devices. You will report to the Global Regulatory & Compliance Leader and 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 Responsibilities

• Collaborate with development teams and production sites to ensure correct implementation of regulatory and normative activities of the products and concerned production sites.
• Be in charge of the resources assessment needed for regulatory and normative activities under your ownership and product platform.
• Collaborate with different teams to contribute to continuous improvement processes.
• Prepare, verify, approve, submit regulatory documents and collect normative information needed for the submission to the authorities, notified body or customers.
• Participate in the drafting, verifying and approving plans and verification reports from internal or external laboratories concerning products under your ownership.
• Contribute and assist when necessary to internal or external audits and propose corrective and preventive actions.
• Collect and interpret elements of the monitored standards, inform product or process managers of the changes, analyze and synthesize 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 their impact, evaluate normative compliance and propose corrective measures if necessary.

Requirements

• Engineering degree or equivalent.
• At least 5 years professional experience.
• Background in combination products or medical devices industry in multicultural and interdisciplinary environments.
• 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, MDR 2017/745, ISO 14971.
• Knowledge of ISO 11608 and ISO 23908 are optional.
• Knowledge of the process of medical device design.
• Good English speaking and written.
• Effective interpersonal skills with ability to work in a team or independently.
• Ability to multi-task and manage priorities with effective 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

• MDR 2017/745
• Generic drugs

Languages

Fluent in English (as it is our company language).

Success Profile

• Passionate about growing a business.
• Enjoy working as a team.
• Proud to make products that improve patients’ lives.
• Go the extra mile to deliver on commitments.

Nemera is an equal opportunity employer and, in accordance with our diversity policy, we review all qualified applications including those of people with disabilities.