Regulatory & Compliance Project Manager
il y a 5 jours
Job Summary
Nemera is seeking a highly skilled Regulatory & Compliance Project Manager to join our team. As a key member of our Regulatory Affairs department, you will be responsible for leading regulatory and compliance design projects for drug delivery devices.
Key Responsibilities
- Collaborate with development teams and production sites to ensure correct implementation of regulatory and normative activities for products and production sites.
- Assess resources needed for regulatory and normative activities and product platforms.
- Contribute to continuous improvement processes across different teams.
- Prepare, verify, approve, and submit regulatory documents and collect normative information for submission to authorities, notified bodies, or customers.
- Participate in drafting, verifying, and approving plans and verification reports from internal or external laboratories for products under ownership.
- Contribute to internal or external audits and propose corrective and preventive actions.
- Collect and interpret monitored standards, inform product or process managers about changes, analyze and synthesize gaps, and collaborate with other departments to ensure 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.
Requirements
- Engineering degree or equivalent.
- At least 8 years of professional experience.
- Background in pharmaceutical or biomedical industry in multicultural and interdisciplinary environments.
- Experience in leading Regulatory & Compliance projects in transversal projects.
- Experience in quality management systems and GMP.
- Advanced knowledge and experience in ISO 11608, ISO 23908, ISO-14971, awareness of IEC, IEC 62304.
- Knowledge of medical device design processes with products such as syringes, autoinjectors, pumps.
- Good English speaking and writing skills.
- 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.
What We Offer
Nemera offers a dynamic and challenging work environment with opportunities for growth and development. We value diversity and inclusion and are committed to creating a workplace where all employees are treated with dignity and respect. We are proud to be an equal opportunities employer and encourage applications from all backgrounds.
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