Regulatory Affairs Expert

vor 2 Wochen

Munich, Deutschland Brainlab Vollzeit

Company Description

Founded in Munich, Germany in 1989, Brainlab develops, manufactures and markets software-driven medical technology, enabling access to improved, more efficient, less-invasive patient treatments. Our key to success is our creative, talented and hard-working team, which consists of around 2000 dedicated and inspiring individuals in 25 locations worldwide. To succeed in reaching our targets, we are seeking committed colleagues who can stand behind our core values curious, authentic and useful.

**Job Description**:
As Regulatory Affairs expert (title will based on your knowledge and experience) you will interact with Brainlab departments and partners internationally and Regulatory Agencies from all over the world. In a cross-functional team you will be involved in the development of various Brainlab products and be responsible for establishing the regulatory strategy. You will interpret regulatory requirements and implement them in projects and/or processes.

Your duties include:

- Provide input to the development team on medical device regulatory considerations.
- Review of the technical documentation of the new/changed medical device.
- Evaluate the design changes and follow up them during development and implementation.
- Discuss general regulatory topics with colleagues from R&D and other departments (marketing, support, sales...).
- Establish global regulatory strategies for the company’s medical devices in collaboration with local partners in all Brainlab subsidiaries.
- Monitor and investigate regulatory requirements in pre-defined countries.
- Contribute and collaborate in adapting the Brainlab Quality System to new/changing regulatory requirements.
- Participate in regulatory audits and follow up improvement opportunities.

**Qualifications**:

- Degree in engineering or life sciences preferred, but other degrees may be considered.
- Professional experience in regulatory affairs or regulatory compliance in the medical device field as a minimum of 3 years is requested. Previous experience in other departments related to medical device development may be considered as well (e.g. in R&D). Title and related compensation will be based on knowledge and experience.
- Strong knowledge of medical device software and related regulatory requirements (IEC 62304, IEC 82304, ISO 14971, cybersecurity...).
- Knowledge of artificial intelligence/machine learning technologies and relevant regulatory requirements is a plus.
- Excellent English written and verbal communication skills
- Ability to communicate with all stakeholders.
- Persuasive power

Additional Information
- A mutually-supportive, international team
- Meaningful work with a lasting impact on medical technology
- 30 vacation days, plus December 24th and December 31st
- Flexible working hours
- Parking garage and safe underground bike storage
- Award-winning subsidized company restaurant and in-house cafes
- Variety-rich fitness program in our ultra-modern 360m2 company gym
- Regular after work, team, and company events
- Comprehensive training and continuing education opportunities

Contact person: Géraldine Endres

  • Regulatory Affairs Specialist

    vor 3 Wochen

    Munich, Deutschland EPM Scientific Vollzeit

    Regulatory Affairs Specialist - Medical Device Manufacturing Project (Bavaria 🇩🇪)We're hiring Regulatory Affairs Specialists for a major medical device manufacturing project based in Bavaria! Join a leading Medical Device Company in a hybrid role supporting regulatory submissions, compliance activities, and alignment with EU and international medical...

  • Regulatory Affairs Manager

    Vor 4 Tagen

    Munich, Deutschland Cpl Life Sciences Vollzeit

    ob Title: European Regulatory Affairs ManagerLocation: Munich, Germany - Hybrid, 3x a week in the officeRemuneration: Competitive salary and packageRegulatory Affairs Manager opportunity working for an established pharmaceutical company that specialises in generic, OTC, and prescription medicines. The business is increasingly growing and is looking for a...

  • Director of Regulatory Affairs

    vor 1 Woche

    Munich, Deutschland Cpl Life Sciences Vollzeit

    **Reference Number**: JO-2304-514347 Director of Regulatory Affairs - (EU Relocation) **Rate**: Negotiable **Job Type**: Permanent **Location**: Munich Director, Regulatory Affairs - Infectious Diseases Munich, Germany /Europe - Relocation Package Provided. **Salary**: Attractive salary plus benefits package (stock options, car allowance, bonus...

  • Working Student in Regulatory Affairs

    Vor 7 Tagen

    Munich, Deutschland Brainlab Vollzeit

    Company Description Founded in Munich, Germany in 1989, Brainlab develops, manufactures and markets software-driven medical technology, enabling access to improved, more efficient, less-invasive patient treatments. Our key to success is our creative, talented and hard-working team, which consists of 1400 dedicated and inspiring individuals in 19 offices...

  • Manager Regulatory Affairs

    vor 2 Wochen

    Munich, Bayern, Deutschland ITF Pharma GmbH Vollzeit 60.000 € - 90.000 € pro Jahr

    Die ITF Pharma GmbH mit Sitz in München ist die deutsche Tochter der Italfarmaco Gruppe. Als familiengeführtes Unternehmen engagieren wir uns in Deutschland und mehr als 90 Ländern dieser Welt leidenschaftlich für die Herstellung und Bereitstellung hochwirksamer Medikamente, ergänzenden medizinischen Lösungen und innovativen Services in den Gebieten...

  • Director of Regulatory Affairs

    vor 1 Woche

    Munich, Deutschland Cpl Life Sciences Vollzeit

    **Reference Number**: JO-2304-514343 Director of Regulatory Affairs -Infectious Disease **Rate**: Negotiable **Job Type**: Permanent **Location**: Munich **Job Title**: Director, Regulatory Affairs - Infectious Diseases **Location**: Munich, Germany - Hybrid working **Salary**: Attractive salary plus benefits package (stock options, car allowance,...

  • Associate Director Regulatory Affairs

    vor 1 Woche

    Munich, Bayern, Deutschland Medella Life Vollzeit 90.000 € - 120.000 € pro Jahr

    Job Purpose / SummaryThe Associate Director (RA) will lead regulatory strategy, submissions, and lifecycle maintenance for assigned products / projects in the European / German / Central Eastern Europe region. This role ensures compliance with regulatory requirements, supports product development from early phase through to post-marketing, and acts as the...

  • Senior Specialist, European Country Regulatory Affairs

    Vor 7 Tagen

    Munich, Deutschland Organon Vollzeit

    Job DescriptionThe PositionCoordinating and supporting all regulatory activities to maintain registrations and to obtain new marketing authorisations for the company portfolio/pipeline subject to EU procedures (Centralised, Mutual Recognition, Decentralised, National authorised Procedures) across therapeutic areas. The position also requires strong project...

  • Regulatory Affairs Specialist Medizinprodukte in Vollzeit

    Vor 6 Tagen

    Munich, Bayern, Deutschland pates GmbH Vollzeit 60.000 € - 80.000 € pro Jahr

    6577MedizintechnikFestanstellung Vor OrtBayernKurzbeschreibung:Innovation trifft VerantwortungRegulatorik mit WirkungMedizinprodukte, die Leben rettenEin international ausgerichtetes Medizintechnikunternehmen mit innovativem Produktportfolio sucht Verstärkung im Bereich Regulatory Affairs. Das Unternehmen verbindet technologischen Fortschritt mit hoher...

  • Senior Regulatory Affairs Manager

    Vor 6 Tagen

    Munich, Bayern, Deutschland Cube4 Consulting Vollzeit 80.000 € - 120.000 € pro Jahr

    Senior Regulatory Affairs Manager (m/w/d)München | Vollzeit | Ab sofortFokus: Zulassungsverfahren, Dokumentation & regulatorische SystemeÜber unsCube4 Consulting ist dein Partner für gezielte Karriereentwicklung und passgenaue Recruiting-Lösungen.Wir begleiten Fach- und Führungskräfte beim nächsten Karriereschritt – diskret, persönlich und...