Senior Regulatory Affairs Manager (m/f/d)
Salary : Negotiable
Location : Zurich
We have an exciting opportunity to work for an established client, operating within the class III medical device market in Zurich. The client is an established leader in the medical device market and operates globally.
Key Responsibilities:
- Implement the new MDR in the regulatory processes with MDD considering for class II - III medical devices.
- Develop and write clear arguments and explanations for new product certifications and license renewals.
- Monitor and set timelines for certification and/or license variations and renewal approvals.
- Provide regulatory intelligence information to the organisation.
- Monitor the regulatory competitor landscape and keep the organisation abreast of potential threats and opportunities jeopardising global development goals.
Key Requirements:
- Master's degree or higher in Life Sciences, Engineering or equivalent
- 3+ years experience within international regulatory affairs
- Profound experience with international medical device (class II & III) regulatory approvals and submissions.
- In depth knowledge of the new MDR and all international regulations.
- Familiar with the medical device and combination device European regulations (93/42/CE and 2001/83/CE).
- Strong understanding of international regulatory landscape & required approaches and strategies.
- Agility to handle and deliver on a multitude of projects, programs, and priorities paired with high sense for execution and teamwork.
- Excellent command of spoken and written English and conversational German (B2), any other language is an asset
