You will be responsible for regulatory documentation and strategy development for medical devices, ensuring compliance and effective communication across departments while monitoring market trends and training staff.
Anforderungen
- •Degree in medical engineering or life sciences preferred
- •Knowledge of medical device regulations
- •Professional experience in regulatory affairs
- •Excellent English and proficient German skills
- •Ability to communicate with stakeholders
- •Independent and structured working style
- •Persuasive power
Deine Aufgaben
- •Collaborate on technical documentation creation and review.
- •Evaluate and follow up on design changes.
- •Document product changes and manage change processes.
- •Discuss regulatory topics with R&D and other departments.
- •Establish global regulatory strategies for medical devices.
- •Compile regulatory submissions for authorities, including 510(k).
- •Monitor and investigate regulatory requirements in specific countries.
- •Participate in regulatory audits and identify improvement opportunities.
- •Conduct regular market monitoring and prepare PMS/PSU reports.
- •Train employees on regulatory requirements.
Deine Vorteile
Mutually-supportive international team
Meaningful work with impact
30 vacation days plus holidays
Flexible working hours
Regular team and company events
Internal fitness program
Comprehensive training opportunities
TOP 100 innovator and employer