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Associate Director Regulatory Affairs
- Posted: 01/03/2023
- Salary: 140000-170000
- Location: Zug, Switzerland
- Job Type: Permanent/Fixed Term
The opportunity to join a patient-centred global medical device company focussing on an oncology portfolio. You will provide strategic input leading your team to sustain regulatory compliance globally, whilst ensuring key clinical insights are upheld to international standards. This position offers global vision across worldwide markets with predominant communication exposure in the European, US and Asian regions.
Responsibilities:
- Obtain and maintain regulatory compliance/approvals across various international markets (US, EU, APAC etc.).
- Engage in communication and build relationships with global notified bodies and competent authorities.
- Lead and be part of all regulatory processes and projects related to clinical studies.
- Guide and advise clinops functions to maintain regulatory compliance in clinical studies.
- Take part in the MDR implementation process.
Experience required
- Advanced life sciences degree in relevant subject or equivalent.
- Several years' experience working in the medical device industry within regulatory functions.
- Several years' experience with a good network/contacts within competent authorities globally.
- Fluency in English (other European languages a bonus).
Hannah Hughes
Team Lead/Senior Consultant