Senior Regulatory Affairs Manager
Job type: Permanent
Location: Munich, Germany
A leading international Medical Device company is currently seeking to hire a Senior Regulatory Affairs Manager to join their growing team in Germany As a Regulatory Affairs Manager you will take ownership of the regulatory strategies and its implementation at the company . You will play a key role in the company's growth strategy and success of their business.
Your responsibilities will include, but are not limited to:
- Develop global regulatory strategies for medical device products to meet business objectives
- Ensure and apply the regulatory knowledge for the assigned regions and countries to create high-quality documentation
- Carry out registration procedures and ensure compliance with internal requirements
- Coordination and implementation of change control processes and continuously tracking and maintaining the CMC submission and approval status
- Ensure all regulatory life cycle management activities and timely responses to authorities' inquiries
- Coordination of regulatory projects with the respective stakeholders and support regulatory strategies
- Take an active part in all audits to fully represent the regulatory section
Key requirements of the Auditor include:
- A minimum Bachelor's degree is required, preferably in a science or engineering field
- At least 5 years of regulatory experience in medical devices field or in a similar position
- Profound knowledge of EU medical device legislation (including 93/42 / EEC; MDR) and DIN EN ISO 13485 and other international regulations
- Business-fluent written and spoken English and good German skills
- Excellent communication skills, flexibility and perseverance
- Detail- and solution-oriented, organized and accurate, successful in driving results.
If you are interested in the role, apply online today.