Senior Regulatory Affairs Manager EMEA
il y a 3 semaines
Are you a seasoned Regulatory Affairs professional looking for a new challenge in the EMEA region? Do you have a passion for ensuring compliance and driving innovation in the medical device industry?
We are seeking a highly experienced Senior Regulatory Affairs Manager to join our team in the EMEA region. As a key member of our Regulatory Affairs team, you will be responsible for leading regulatory activities across the region, ensuring compliance with European regulations, and collaborating with cross-functional teams to drive business growth.
Key Responsibilities:- Lead regulatory activities in the EMEA region, ensuring compliance with European regulations and guidelines.
- Develop and implement regulatory strategies to support business growth and innovation.
- Collaborate with cross-functional teams, including R&D, Manufacturing, and Quality, to ensure regulatory compliance and drive business success.
- Manage regulatory requests from internal stakeholders, including product design, change management, and post-market activities.
- Act as the primary contact for regulatory requests related to European operations activities, such as repackaging or relabeling.
- Develop and maintain relevant instructions and procedures applicable to regulatory activities.
- Support the effective execution of FSCA and FCA in the EMEA region, from planning to report writing and follow-up.
- Minimum 7 years of experience in Regulatory Affairs positions in the medical device industry, including design/manufacturing and risk management principles.
- Excellent knowledge of the regulatory and normative framework of Medical devices in Europe (MDD and MDR related).
- Ability to understand and interpret new requirements/regulations.
- Fluent in French and English (written and oral).
- Experience in team management.
- Flexibility: Enjoy a supportive work environment with flexible office options that promote a healthy work-life balance.
- Growth and Development: Work with a manager who is passionate about helping her team develop their skills and grow in their careers.
- Leadership Opportunity: Manage managers, take on key responsibilities, and lead impactful projects.
- Positive and Dynamic Environment: Thrive in a fun, collaborative atmosphere where innovation is at the heart of everything we do.
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