Regulatory Affairs Expert for EU and US Regions
vor 3 Wochen
We are a leading company in the design and manufacturing of hyaluronic acid-based dermal fillers and dermocosmetics.
Our team is passionate about providing global patient care, and we use our products to help practitioners restore youthful volume to the face, treat the neck and décolleté, and achieve natural results.
About the RoleWe are looking for an experienced Regulatory Affairs professional to join our team as Head of Regulatory Affairs (EU & US regions).
This role will be focused on managing the EU & US regulatory team dedicated to Innovation & Life-cycle projects.
The ideal candidate will have strong leadership skills, excellent communication abilities, and a deep understanding of EU and US regulations.
You will be responsible for developing the regulatory strategic roadmap, providing strategic mentorship, and contributing to key strategic decisions impacting the development of global regulatory compliance processes and procedures.
In addition, you will oversee the compilation of regulatory submission files, contribute and review responses to questions raised by the Notified Body and FDA, and support life-cycle management activities.
As a leader, you will ensure product compliance with EU and US regulations and standards, lead preparatory activities, and promote RA excellence by supporting the establishment, maintenance, and optimization of Regulatory Affairs processes and procedures.
Responsibilities- Develop the regulatory strategic roadmap according to business objectives and provide regulatory leadership for programs in the pre-market and post-market space.
- Mentor the regulatory team and ensure alignment of regulatory strategies with business objectives and implementation of strategic plans.
- Contribute to key strategic decisions impacting the development of global regulatory compliance processes and procedures.
- Monitor the implementation of new EU & US requirements through the regulatory intelligence process and adapt the strategy accordingly.
- Oversee the compilation of regulatory submission files for new products and product changes to achieve timely submissions/approvals (including IDE and PMAs).
- Support life-cycle management activities (including change control regulatory impact assessment for EU & US regions).
- Ensure product compliance with EU & US regulations and standards.
- Degree in a relevant field, such as law, medicine, or science.
- Minimum 10 years of experience in regulatory affairs, preferably in the medical device industry.
- Strong knowledge of EU and US regulations and standards.
- Excellent leadership and communication skills.
- Ability to take ownership and responsibility for actions and decisions.
The salary range for this position is between $120,000 - $180,000 per year, depending on experience and qualifications. In addition, we offer a comprehensive benefits package, including health insurance, retirement plan, and paid time off.
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