Regulatory Affairs Director EU
vor 12 Stunden
About Teoxane Laboratories
Teoxane Laboratories, a company dedicated to innovation and excellence, is seeking a highly skilled Regulatory Affairs Director to lead our EU and US regulatory team. With a strong focus on strategic expertise and leadership, this role will play a crucial part in ensuring compliance with EU and US regulations for our innovative products.
Key Responsibilities
- Develop Regulatory Roadmap: Create and implement a regulatory strategic roadmap aligned with business objectives, ensuring timely submissions and approvals for our products.
- Regulatory Leadership: Provide strategic guidance and leadership to cross-functional teams, ensuring regulatory strategies are aligned with business objectives.
- Regulatory Intelligence: Monitor new EU and US requirements, adapting our strategy to ensure compliance and business success.
- Regulatory Strategy: Contribute to key strategic decisions impacting global regulatory compliance processes and procedures.
- Regulatory Submission: Oversee the compilation of regulatory submission files, ensuring timely submissions and approvals.
- Regulatory Excellence: Ensure RA excellence by supporting establishment, maintenance, and optimization of Regulatory Affairs processes and procedures.
Requirements and Skills
- Deputy PRRC diploma and experience.
- Minimum 10 years of experience in regulatory affairs.
- Expertise in EU and US regulations, with a strong background in high-risk medical devices.
- Strong leadership and team management skills.
- Ability to resolve problems and make regulatory decisions.
- Experience in negotiating with regulatory agencies and Notified Bodies.
- Strong analytical skills and strategic thinking.
- Ability to work in a dynamic environment.
- Fluency in English.
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