About the role
The Regulatory Affairs Manager (m/f/d) is responsible for leading the regulatory strategy and execution for a portfolio of products. This includes regulatory submissions, interactions with health authorities, and implementation of regulatory requirements. Key responsibilities include:
- Developing and implementing regulatory strategies, plans, and submissions for a portfolio of products
- Serving as the primary regulatory subject matter expert and point of contact for the product team
- Providing regulatory guidance and leadership to cross-functional teams
- Coordinating the preparation and submission of regulatory applications
- Monitoring and analyzing regulatory trends and changes to ensure ongoing compliance
- Representing the company in regulatory authority meetings and inspections
- Collaborating with global regulatory affairs team to ensure alignment and consistency
Qualifications:
- Bachelor's degree in a life sciences, engineering, or related field
- 5+ years of experience in regulatory affairs, preferably in the medical device industry
- Strong knowledge of global regulatory requirements and processes
- Excellent communication and interpersonal skills
- Ability to work collaboratively in a cross-functional team environment
- Proficient in MS Office applications
About the company
Siemens Healthineers is a leading medical technology company with over 120 years of experience and 66,000 employees in more than 70 countries. We are passionate about innovating healthcare, creating technologies shaping the future of medicine.
