Description
We are looking for a
Regulatory Affairs Manager (m/f)
Reference: -en
Start: asap
Duration: 6 MM+
Place: in the Zurich region
Branch: Herstellung von medizinischen und zahnmedizinischen Apparaten und Materialien
Your tasks:
- Development and execution of regulatory strategies for assigned projects on implant systems in major markets, i.e. EU, USA, CAN and AUS
- Accountable for regulatory compliance and support of product development in cross functional teams
- Creation, review and/or approval of documents of the design control process
- Support international product registration by advising the responsible Regulatory Affairs Manager in international projects
- Assessment, approval and regulatory implementation of change requests
- Review and approval of product related labelling and marketing material
- Support SAP-based reporting system
- Provide internal training with respect to relevant procedures and requirements
Your qualifications
- Scientific or technical background, university degree is of advantage
- Profound experience in regulatory affairs within the medical device industry
- Good knowledge of medical device legislation EU, USA, CAN and AUS and corresponding guidelines
- Good knowledge of product development processes in the medical device industry
- Good knowledge of quality system requirements such as ISO 13485 and FDAs 21 CFR Part 820
- Experience in preparation of notified body audits and FDA inspections
- Experience with EU, US, AUS and CAN medical device regulations
- Fluency in English, further languages (especially German) are of advantage
- Strong interpersonal, writing and communication skills, ability to work in an international matrix organisation
Skills:
- Regulatory affairs manager
Keywords: Regulatory Affairs Medical Devices Dental ISO 13485 FDA 21 CFR Part 820 design control Reg. Affairs