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Regulatory Compliance Project Manager
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We are seeking a highly skilled Regulatory & Compliance Project Manager to join our team at Nemera France SAS. As a key member of our Insight headquarters, you will lead the regulatory & compliance design projects of drug delivery devices.
Key Responsibilities:- Collaborate with the development team and production sites to ensure correct implementation of regulatory and normative activities.
- Assess resources needed for regulatory and normative activities and product platforms.
- Contribute to continuous improvement processes and collaborate with different teams.
- Prepare, verify, approve, and submit regulatory documents and collect normative information.
- Participate in drafting, verifying, and approving plans and verification reports from internal or external laboratories.
- Contribute to internal or external audits and propose corrective and preventive actions.
- Collect and interpret monitored standards, inform product or process managers, and analyze and synthesize gaps.
- Summarize regulatory and/or normative requirements and provide training to project, plant, marketing, and sales teams.
- Support Insight teams during product-specific normative interactions with external stakeholders.
- Participate in standard committees and external expert groups to understand, anticipate, and influence existing or new standards.
- Conduct in-depth analyses of proposed product changes, assessing their impact, evaluating normative compliance, and proposing corrective measures.
- 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 medical device design with products such as syringes, autoinjectors, pumps.
- Good English speaking and writing skills.
- International committee experience.
- 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.
Our Recruitment Process
We believe in a transparent and straightforward recruitment process to ensure a great fit for both you and our team. Here's what you can expect:
- CV Review: Upon receiving your CV, our Talent Acquisition Team will review it to assess your qualifications for the role.
- Initial Screening: If your profile matches our requirements, you'll be invited for an initial screening call with a member of our Talent Acquisition Team.
- Interview with Hiring Manager: After the initial screening, you'll have an interview with the Hiring Manager to discuss your experience, skills, and fit for the role in more detail.
- Interview with N+2: Following the Hiring Manager interview, you'll meet with the next level of management (N+2) for further evaluation.
- HR Manager Interview: The final step involves an interview with our HR Manager to discuss company culture, benefits, and other HR-related topics.
- Offer: If all goes well, you'll receive an offer to join our team.
We look forward to receiving your application (resume submitted in English is appreciated). We offer varied jobs in an international group. If you want to discover more about Nemera, please look at our website
