Regulatory Affairs Expert for Medical Device Innovation

Vor 6 Tagen


Genf, Genf, Schweiz Teoxane SA Vollzeit

About Teoxane SA

We are a specialized company in the design and manufacturing of hyaluronic acid-based dermal fillers and dermocosmetics. Our strength lies in offering global patient care, allowing practitioners to restore youthful volume to the face and treat the neck and décolleté with natural results.

In our quest for growth, we seek an exceptional professional to join our team as:

Regulatory Affairs Expert for Medical Device Innovation

Job Description

This role will be responsible for managing the EU & US regulatory team dedicated to Innovation & Life-cycle projects under the supervision of the Regulatory Affairs Director.

The successful candidate will provide strategic expertise and leadership to business partners and stakeholders, ensuring alignment of regulatory strategies with business objectives.

Main Responsibilities:

  • Develop and implement regulatory strategic roadmaps to achieve business objectives.
  • Provide mentorship and guidance to ensure effective implementation of strategic plans.
  • Contribute to key strategic decisions impacting global regulatory compliance processes and procedures.
  • Monitor new EU & US requirements through regulatory intelligence and adapt strategies accordingly.
  • Collaborate with cross-functional teams to define regulatory pathways and develop strategies for submission to Notified Body and FDA.
  • Oversee the compilation of regulatory submission files for new products and product changes to achieve timely submissions/approvals.
  • Review responses to questions raised by Notified Body and FDA to ensure accurate and complete answers.
  • Support life-cycle management activities, including change control regulatory impact assessments.
  • Ensure product compliance with EU & US regulations and standards.
  • Lead preparatory activities, including briefing packages for interactions with FDA.
  • Establish and maintain regulatory excellence by optimizing processes and procedures.
Requirements and Skills

To succeed in this role, you must possess:

  • A strong background in regulatory affairs, with a focus on medical devices.
  • A minimum of 10 years of experience in a related field.
  • Expertise in EU & US regulations, with a proven track record of navigating high-risk medical devices.
  • Proven leadership skills, with at least one team management experience.
  • Strong analytical and problem-solving abilities.
  • Excellent communication and negotiation skills.
  • The ability to work in a dynamic environment and handle multiple projects simultaneously.
  • Fluency in English.
Estimated Salary Range: $120,000 - $150,000 per year

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