Regulatory & Compliance Project Manager
il y a 4 semaines
Nemera is a leading global manufacturer of complex drug delivery systems for the pharmaceutical industry. We are seeking a highly motivated and experienced Regulatory & Compliance Project Manager to join our team in Lyon, France.
Key Responsibilities- Lead regulatory & compliance design projects of drug delivery devices
- Collaborate with development team and production sites to ensure correct implementation of regulatory and normative activities
- Assess resources needed for regulatory and normative activities under ownership and product platform
- Prepare, verify, approve, submit regulatory documents, and collect normative information needed for submission to authorities, notified bodies, or customers
- Participate in drafting, verifying, and approving plans and verification reports from internal or external laboratories concerning products under ownership
- Contribute and assist when necessary to internal or external audits and propose corrective and preventive actions
- Collect and interpret elements of monitored standards, inform product or process managers for changes, analyze and synthesize gaps, and collaborate with other departments to guarantee normative compliance
- 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, such as regulatory organisms and customers
- Participate in standard committees and external expert groups to understand, anticipate, and influence existing or new standards
- Conduct in-depth analyzes of proposed product changes, assessing their impact, evaluating normative compliance, and proposing corrective measures if necessary
- 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, 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)
- 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
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