Regulatory Affairs Specialist / Deputy PRRC

Freyr Solutions; München; Vor Ort; EUR 50.000 - 80.000; Vollzeit

Zusammenfassung

An innovative company is seeking a passionate Regulatory Affairs Specialist to join their expanding team in Germany. This role involves ensuring compliance with MDR and IVDR regulations while supporting manufacturers in navigating the complex regulatory landscape. You will be responsible for preparing compliance documents, acting as a liaison with authorities, and delivering regulatory intelligence projects. Join a collaborative environment where your expertise will shape the future of regulatory services in the Life Sciences industry. This is an exciting opportunity for professionals eager to make an impact in a fast-growing firm.

Qualifikationen

• 3+ years experience in Regulatory Affairs for medical devices.
• PRRC qualifications with recognized formal education or certification.

Aufgaben

• Ensure manufacturer compliance with MDR and IVDR as a QA/RA expert.
• Act as a point of contact for Notified Bodies and Competent Authorities.
• Prepare and review SOPs and compliance documents.

Kenntnisse

Regulatory Compliance

MDR

IVDR

Quality Assurance

Project Management

German Language Proficiency

Ausbildung

Bachelor's degree in Life Sciences

Bachelor's degree in Engineering

Bachelor's degree in Pharmacy

Jobbeschreibung

Please do not apply if you are located outside Germany.

About Freyr

Freyr is a fast-growing, innovative company specializing in providing end-to-end regulatory solutions and services for the Life Sciences industry. We assist pharmaceutical, medical device, and biotech companies in navigating regulatory compliance.

Why Freyr?

We foster a collaborative and dynamic work environment that empowers our team. As we expand to Warsaw, Poland, we seek passionate Regulatory professionals to join us in shaping the future of regulatory services.

Join Our Team

If you're ready for growth and innovation, connect with us to explore opportunities at Freyr. Together, we can redefine regulatory excellence.

To Apply

Please apply through this job post or visit our Careers page for more openings. Don't miss your chance to be part of our expansion and make an impact in regulatory services.

Position Details

Title: Regulatory Affairs Specialist / Deputy PRRC

Location: Germany

Experience: 3+ years in MDR, proficiency in German is required

Primary Responsibilities

1. Perform duties of Person Responsible For Regulatory Compliance (PRRC) as per MDR and IVDR.
2. Ensure manufacturer compliance with MDR and IVDR as a QA / RA expert.
3. Prepare and review SOPs and compliance documents.
4. Act as a point of contact for Notified Bodies and Competent Authorities.
5. Support registration processes and conduct gap assessments of internal regulatory systems.
6. Review technical files for EU compliance.
7. Deliver regulatory intelligence projects and interpret guidelines.
8. Prepare artefacts like checklists and presentations for project delivery.
9. Provide PMS support for projects with PRRC responsibility.
10. Coordinate with cross-functional teams and clients to monitor project progress.
11. Communicate with manufacturers and authorities, archive communications.
12. Manage operational aspects and deliverables of projects.
13. Identify risks and issues proactively and alert stakeholders.
14. Ensure proper archiving of project deliverables.
15. Support audits from notified bodies and authorities.
16. Develop and maintain project metrics, timelines, and tools.
17. Support database and registration portal maintenance in Europe.
18. Ensure compliance of products with MDR, IVDR, MDD, and other relevant regulations in Europe and Switzerland.

Secondary Responsibilities

• Analyze regulations and develop regulatory strategies for new medical device registrations.
• Stay updated on evolving European regulations and their impacts.
• Participate in meetings and training activities.
• Manage individuals and projects effectively.
• Resolve conflicts and translate strategy into regulatory programs.
• Achieve goals aligned with business needs.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, Biological Science, Pharmacy, or related field.
• 3+ years' experience in Regulatory Affairs for medical devices.
• PRRC qualifications, with recognized formal education or certification.
• At least one year of professional experience in regulatory affairs or quality management systems related to medical devices, aligned with EU requirements.