Global Regulatory Compliance Manager for EU and US Regions
vor 2 Wochen
Established in Geneva, Switzerland, in 2003, Teoxane Laboratories is a specialist in the design and manufacturing of hyaluronic acid-based dermal fillers and dermocosmetics.
Job OverviewWe are seeking a highly experienced Global Regulatory Compliance Manager to oversee the management of our EU and US regulatory team dedicated to Innovation & Life-cycle projects.
Main Responsibilities:- Develop Strategic Roadmap: Develop and implement the regulatory strategic roadmap according to business objectives and provide regulatory leadership for programs in the pre-market and post-market space.
- Mentorship and Leadership: Provide strategic mentorship to ensure alignment of regulatory strategies with business objectives and implementation of strategic plans.
- Regulatory Intelligence: Monitor the implementation of new EU and US requirements through the regulatory intelligence process and adapt the strategy accordingly.
- New Product Development: Contribute to regulatory strategy in the framework of new products development in collaboration with cross-functional teams by defining regulatory pathways and developing regulatory strategies for submission to Notified Body and FDA.
- Submission Management: Oversee the compilation of regulatory submission files for new products and product changes to achieve timely submissions/approvals (including IDE and PMAs).
- Communication: Ensure effective communication across the global Regulatory Affairs team and lead the preparatory activities including briefing package for interactions with FDA.
- Regulatory Expertise: You have the diploma and experience to act as Deputy PRRC and possess extensive knowledge of EU and US regulations.
- Leadership Experience: We are looking for an expert with significant experience in the medical device field (high-risk medical devices) with strong leader experience and at least one Team management experience.
- Critical Thinking: Strong ability to take ownership and responsibility for actions, resolve problems, and make regulatory decisions.
- Negotiation Skills: Experience in negotiating with regulatory agencies and Notified Body.
- Project Management: Ability to handle multiple projects simultaneously.
- Strong Analytical Skills: Strong analytical skills and strategic thinking with leadership ability.
- Diversity and Inclusion: Ability to work in a dynamic environment and communicate effectively with diverse stakeholders.
- Language Skills: Fluency in English.
The estimated salary for this role is around $120,000 - $180,000 per year, depending on experience and qualifications.
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