Regulatory & Compliance Project Manager F/M/X

Regulatory & Compliance Project Manager F/M/X

• Full-time
• Employment Classification: Cadre
• Nemera Department: Global Quality & Regulatory

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 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 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).

Job Description

• 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 be in charge of the resources assessment needed for regulatory and normative activities under your ownership and product platform.
• You will collaborate with different teams to contribute to the continuous improvement processes.
• You will 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.
• 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.
• You will summarize regulatory and/or normative requirements.
• Support Insight teams during product‑specific normative interactions with external stakeholders, such as regulatory organisms and customers.
• You will participate in standardization committees and external expert groups 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.

Requirements

• Engineering degree or equivalent
• At least 5 years professional experience
• Background in the combination products or medical devices 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
• 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 Qualities

• 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 your commitments

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