Regulatory Affairs Manager (m/f/d)
Regulatory Affairs Manager (m/f/d)
Full-time
immediately
Tuttlingen
The continuous further development of our products as well as the implementation of innovative ideas have made us an internationally active and successful company:
STORZ & BICKEL is the first and only manufacturer of certified medical devices for the inhalation of cannabinoids.
Our company is growing steadily – and we would love to grow with you.
Regulatory Affairs Manager (m/f/d) Your Tasks Product Conformity & Approvals
- Responsibility for product approvals and their maintenance in cooperation with Notified Bodies, authorities, and other regulatory contacts
- Support and evaluation of changes subject to notification
- Implementation of Post-Market Surveillance activities
Identification of standard requirements for our products
- Derivation of product requirements for new developments based on relevant standards and regulatory specifications
- Analysis and evaluation of regulatory changes regarding their impact on the existing portfolio as well as initiation of appropriate measures
Support of product developments
- Coordination and support of development-accompanying risk management activities
- Planning and coordination of external testing (EMV, biocompatibility, electrical safety, etc.)
- Ensuring complete, consistent, and standard-compliant technical documentation
Your Profile
- You have a completed degree in a technical or scientific field
- You possess sound knowledge of the MDR (EU) 2017/745 as well as other international approval requirements (e.g., Canada, Australia, Brazil)
- You have experience in implementing the requirements of relevant standards such as ISO 14791, IEC 60601-1, IEC 62304, and ISO 10993
- You have experience in project management
- You possess very good written and spoken English skills
- Careful and proactive working is a matter of course for you
- You are a strong-communicating team player (m/f/d) and look forward to an interface role
Why STORZ & BICKEL
- A workplace in a state-of-the-art company building offers you a very pleasant working atmosphere
- Flat hierarchies and short decision-making paths enable you to achieve a lot
- We offer you a competitive compensation package including holiday and Christmas bonuses
- With us, you receive 30 days of paid vacation and a special day off for your birthday
- Free drinks and fruit are a matter of course for us
- A dynamic and motivated team awaits you, which also enjoys coming together during company events (e.g., Christmas party and summer festival)
- If you do not live in Tuttlingen, you will receive a subsidy from us for your travel costs
- If interested, we subsidize your company pension scheme
- JobRad: We promote your company bicycle with a monthly salary subsidy of €65.00, keeping our employees fit and protecting the environment
- We support your fitness through a Hansefit partnership (personal contribution only €19.50)
We look forward to your application - please apply directly via our homepage and stating your salary expectations (gross annual salary).
Any questions?
We are happy to be there for you!
Contact person: +49(7461)969707-0 jobs@storz-bickel.com
STORZ & BICKEL GmbH In Grubenäcker 5–9, 78532 Tuttlingen jobs@storz-bickel.com www.storz-bickel.com