Regulatory & Compliance Project Manager (F/H)/x

il y a 3 semaines

Lyon, France Nemera Insight - R&D Department Temps plein

**Company Description**
With sales of €600m and 3000 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 Lyon (7e).

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 & Compliance Project Manager F/M/X**, based in Lyon (7e).

Within Nemera’s Insight headquarters, you will lead the regulatory & compliance design projects of drug delivery devices. You will report to the Global Regulatory & Compliance Leader. You will work closely with the development team, from requirements through to architecture, development, industrialisation, quality, covering all aspects from defining regulatory strategy, and supporting quality management plans through to QMS development and process improvement.
- You will collaborate with development team and with the production sites 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 and provide a training to the project, plant, marketing and sale teams.
- Support Insight teams during product-specific normative interactions with external stakeholders, such as regulatory organisms and customers.
- You will participate in standard committee 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

**Qualifications**
- Engineering degree or equivalent
- At least 8 years of professional experience
- 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 and GMP
- Advanced knowledge and experience in ISO 11608, ISO 23908, ISO-14971, awareness of IEC 60601-1, IEC 62304
- Knowledge of the process of medical device design with products such as syringes, autoinjectors, pumps
- Good English speaking and written
- International committee experience (technical discussions with another committee member who may be a competitor)

**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 skills

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
**Additional Information**
**Our Recruitment Process**

We believe in a transparent and straightforward recruitment process to ensure a great fit for both you and our

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