Regulatory & Compliance Project Manager

il y a 2 semaines

Lyon, Auvergne-Rhône-Alpes, France NEMERA Temps plein

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 & compliance design projects of drug delivery devices.

Key Responsibilities

  • Collaborate with development teams and production sites to ensure correct implementation of regulatory and normative activities of products and concerned production sites.
  • Assess resources needed for regulatory and normative activities under your ownership and product platform.
  • Contribute to continuous improvement processes by collaborating with different teams.
  • Prepare, verify, approve, and 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 your ownership.
  • Contribute and assist with 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.

Requirements

  • 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 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.

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