Regulatory Affairs Manager M/F/X (CDI)

Women First; Lyon; Hybrid; EUR 90.000 - 130.000; Vollzeit

Benefits dieser Stelle

Remote work 2 days/week

Zusammenfassung

Nemera, a leading global medical device manufacturer, is seeking a Regulatory Affairs Manager based in Lyon (7e). You will lead Regulatory & Compliance activities for ENTD, Ophthalmic and Inhalation products, shaping regulatory strategies across EU, US and Canada.

You will collaborate with development, quality, logistics and commercial teams, supervise a Regulatory & Compliance team, and ensure oversight through ISO13485, MDR 2017/745, and post‑market activities.

Qualifikationen

• Master’s degree in life sciences or related field with regulatory emphasis.
• 8+ years in medical devices, preferably with combination products.
• Experience leading regulatory projects and teams.

Aufgaben

• Lead Regulatory & Compliance for ENTD, Ophthalmic and Inhalation products.
• Oversee regulatory strategies, submissions and lifecycle activities.
• Coordinate with development, quality, and operations teams.
• Support audits and regulatory interactions with authorities and customers.
• Guide notifications in EU/US/Canada and maintain QMS alignment.

Kenntnisse

Regulatory leadership

Team management

MDR 2017/745

ISO 13485

IEC 62304

ISO 10993

English proficiency

Cross-functional collaboration

Ausbildung

Master's degree or higher

Jobbeschreibung

With sales of €700m and 3,300 employees worldwide, Nemera is one of the leading global manufacturers of complex drug delivery systems for the pharmaceutical industry, offering to patients a broad product portfolio which includes inhalation devices, injection devices, nasal and dermal pumps and ophthalmic delivery devices. Nemera has built very long lasting, strong relationships with the leading global pharmaceutical companies globally by providing high quality development, industrialization and manufacturing services. Nemera develops and manufactures its own IP product platforms but also offers also fully custom developments and contract manufacturing.

Nemera’s manufacturing sites are located in the US, France, Germany, Brazil and Poland. The headquarters and Innovation Center for early device design and development are located in France (Lyon).

We have big ambitions at Nemera! We are growing our franchises and strengthening our capabilities.

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 & 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

Required profile:

• Master’s degree or higher in life sciences or sciences (Pharmacist, Master in Regulatory Affairs).
• At least 8 years of professional experience in the medical devices industry (ideally, combination products)
• Experience in managing and developing teams
• Background in pharmaceutical or biomedical industry in multicultural and interdisciplinary environment.
• Experience in leading Regulatory & Compliance projects in transversal projects
• Experience in quality management system (ISO13485) and Risk Management (ISO 14971)
• Advanced knowledge and experience inMDR 2017/745, awareness of IEC 62304 and ISO 10993
• Good English speaking and written
• International committee experience

Soft skills:

• 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
• Confident communicator, both verbally and in writing, and in presenting information concisely to others in a group or one to one setting
• Analytical and synthetical skills

Some travels are required. We offer the possibility of working from home 2 days per week.

If you are:

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

Then you'll be successful here!