Regulatory Affairs Specialist / Deputy PRRC

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

Zusammenfassung

An innovative company is seeking a Regulatory Affairs Specialist to enhance their regulatory services in the Life Sciences industry. This role involves ensuring compliance with MDR and IVDR, managing projects, and acting as a liaison with regulatory bodies. You will play a crucial role in navigating the complexities of regulatory compliance, supporting product registrations, and maintaining high standards of quality assurance. If you are passionate about regulatory affairs and eager to contribute to a dynamic team, this is an exciting opportunity to make a significant impact in a fast-growing organization.

Qualifikationen

• 3+ years of experience in Regulatory Affairs for medical devices.
• PRRC qualifications and recognition of qualifications outside the EU.

Aufgaben

• Perform duties of Person Responsible For Regulatory Compliance (PRRC).
• Prepare and review SOPs and compliance documents.
• Act as a point of contact for Notified Bodies and Authorities.

Kenntnisse

Regulatory Compliance

MDR Proficiency

Quality Assurance

German Language

Project Management

Ausbildung

Bachelor's in Life Sciences

Bachelor's in Engineering

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. With a commitment to excellence and innovation, we assist pharmaceutical, medical device, and biotech companies in navigating the complexities of regulatory compliance.

Why Freyr?

At Freyr, we believe in fostering a collaborative and dynamic work environment that empowers our team to make a real impact. As we expand our footprint to Warsaw, Poland, we are seeking passionate and skilled Regulatory professionals to join us in shaping the future of regulatory services.

Join Our Team :

If you're ready to embark on a journey of growth and innovation, connect with us to explore the exciting opportunities at Freyr. Together, we can redefine regulatory excellence.

To Apply :

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

Title : Regulatory Affairs Specialist / Deputy PRRC

Location : Germany

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

Primary Responsibilities :

1. Perform duties of Person Responsible For Regulatory Compliance (PRRC) as per MDR and IVDR.
2. Work as a QA / RA expert ensuring compliance with MDR and IVDR.
3. Prepare and review SOPs and compliance documents.
4. Act as a point of contact for Notified Bodies / Authorities.
5. Support registration processes and perform gap assessments.
6. Review technical files for EU compliance.
7. Deliver regulatory intelligence projects and interpret guidelines.
8. Prepare artefacts like checklists and presentations.
9. Provide PMS support where responsible as PRRC.
10. Coordinate with cross-functional teams and clients.
11. Communicate with manufacturers and authorities, archive communications.
12. Manage operational aspects of projects, monitor timelines.
13. Identify risks/issues and alert stakeholders.
14. Ensure proper archiving of deliverables.
15. Support audits from notified bodies and authorities.
16. 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 regional regulations.

Secondary Responsibilities :

1. Analyze regulations for compliance strategies.
2. Stay updated on evolving European regulations.
3. Participate in meetings and training activities.
4. Manage projects and conflicts effectively.
5. Translate strategy into regulatory programs.
6. Achieve goals aligned with business needs.

Qualifications :

• Bachelor's in Life Sciences, Engineering, or related field.
• 3+ years' experience in Regulatory Affairs for medical devices.
• PRRC qualifications (required).
• Recognition of qualifications outside the EU.
• At least one year of professional experience in regulatory affairs or quality management systems related to medical devices, aligned with EU requirements.