As one of the world’s leading analytical instrumentation companies, Bruker covers a broad spectrum of advanced solutions in all fields of research and development. All our systems and instruments are designed to improve safety of products, accelerate time-to-market and support industries in successfully enhancing quality of life. We’ve been driving innovation in analytical instrumentation for 60 years now. Today, worldwide more than 7,200 employees are working on this permanent challenge, at over 70 locations on all continents.
The Head of Regulatory Affairs is responsible for managing international IVD medical device registrations and ensuring regulatory compliance of products and services provided by Hain Lifescience, a company belonging to the Business Area Microbiology & Diagnostics (M&D), Bruker Daltonics GmbH & Co. KG, including support of existing and new products. This role will work cross-functionally with other departments in particular R&D, Quality and Product Management and with other Bruker Microbiology & Diagnostics sites to ensure compliance with the global regulatory strategy.
Head of Regulatory Affairs (m/f/n) - M&D
- Manage local medical device regulatory affairs, including resources, schedules, and budget, in alignment with the Hain Lifescience/Bruker Microbiology & Diagnostics business strategy and the Microbiology & Diagnostics/Bruker Daltonics Division global regulatory strategy.
- Provide regulatory support to colleagues across all departments, especially R&D and Product Management, throughout the design and development process and the entire product lifecycle.
- Communicate changes and new requirements in standards and regulations as necessary to senior management, R&D, Product Management, and Quality Management.
- Work closely with Quality Management to ensure all applicable external regulations and quality standards relating to activities and products are met and the required processes are implemented by Quality Management.
- Establish and implement necessary communication strategy to ensure awareness of regulatory issues across all departments.
- Contribute to M&D/divisional regulatory strategy and where requested, assist in implementation at other sites of the Bruker Daltonics Division.
- Together with Quality Management, assume responsibility for regulatory compliance within Hain Lifescience (Person Responsible for Regulatory Compliance, PRRC).
- Ensure Regulatory Affairs team members are adequately trained (internal/external training as appropriate) for their prescribed roles.
- Where appropriate, train members of R&D, Product Management, and other staff in regulatory matters, including Medizinproduktberater (medical product advisors) under German Law.
Education and/or Experience:
- Master’s degree or higher in a specific scientific/engineering field, or demonstrably equivalent training and experience.
- Multi-year experience in an IVD regulatory affairs environment including preparation & maintenance of technical dossiers and registration of IVDs within Europe and beyond (e.g. CE, FDA, MDSAP etc). Regulatory/registration experience related to molecular biology IVD products would be beneficial.
- Experience in managing a cross-functional team is preferred.
- In-depth knowledge of regulatory requirements and standards for IVD medical devices within the EU and beyond (e.g. IVDD / IVDR, FDA 510(k), ISO 13485, ISO 14971 etc).
Other Skills and Abilities:
- Fluency in German and English.
- Ability to communicate with regulatory authorities, notified bodies, and scientific reviewers is essential.
- Excellent written and verbal communications skills, including the ability to motivate diplomatically.
- Management skills, including the ability to organize a team, delegate tasks, and meet deadlines as necessary.
- Willingness to be hands-on where necessary.
- Problem-solving – turning “no” into “yes”.