We are currently looking for passionate people ready to make a difference in the following open position: Regulatory Affairs Manager F/M/X, based in Lyon (7e).
Within Nemera’s headquarters, you will lead the Regulatory & Compliance activities for a diverse portfolio of ENTD (Ear, Nose, Throat & Dermal), Ophthalmic and Inhalation medical devices and combination products, covering different regulatory pathways and risk profiles.
You will report to the Global Regulatory & Compliance Manager, and work in close collaboration with development, quality, industrialisation, operations and commercial teams, as well as with customers and external stakeholders.
You will be involved throughout the full product lifecycle, from early development phases to post-market activities, defining regulatory strategies, supporting quality management plans and contributing to QMS development and continuous improvement.
Job Description :
- You will manage the Regulatory & Compliance team of the Business Units ENTD and Ophthalmic and Inhalation Products.
- You will be in charge of the resources assessment needed for regulatory and normative activities under your ownership and product platform.
- You will collaborate with Regulatory and Compliance Project Managers in building the product regulatory strategy and regulatory impact assessment of changes, linked to the device part and combination products.
- You will collaborate with development teams and with the production site(s) to ensure correct implementation of regulatory and normative activities of the products and concerned production sites.
- You will support and guide our customers in their notification procedure particularly in EU, US and Canada.
- You will collaborate with different teams to contribute to the continuous improvement processes.
- You will support the Regulatory Team in the preparation, verification and approval, of regulatory documents and collect normative information needed for the submission to the authorities, notified body or customers.
- Contribute and assist when necessary to internal or external audits and propose corrective and preventive actions.
- You will collect and interpret elements of the monitored standards, inform product or process managers for the changes, analyze and synthesize gaps and collaborate with other departments of the company to guarantee normative compliance.
- Support development teams during product-specific normative interactions with external stakeholders, such as regulatory organisms and customers.
- You may participate in standardization committees and external expert groups in order to understand, anticipate and influence existing or new standards.
- You will conduct in-depth analyzes of proposed product changes, assessing their impact, evaluating the normative compliance and proposing corrective measures if necessary
- Collaborate closely with other BUs