Regulatory Affairs Specialist / Deputy PRRC

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

Zusammenfassung

An innovative firm is seeking a passionate Regulatory Affairs Specialist to join their dynamic team in shaping the future of regulatory services. With a focus on compliance within the Life Sciences industry, this role offers the opportunity to work on impactful projects that ensure adherence to MDR and IVDR regulations. The successful candidate will collaborate with cross-functional teams, manage communications with manufacturers, and oversee project operations. If you're ready to make a real impact in a fast-growing company, this is the perfect opportunity for you to thrive and grow.

Qualifikationen

• 3+ years in Regulatory Affairs for medical devices.
• PRRC qualifications required for compliance.

Aufgaben

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

Kenntnisse

Regulatory Compliance

MDR Proficiency

Quality Assurance

Project Management

Analytical Skills

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. 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 to make a real impact. 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

Apply via this job post or visit our Careers page for more openings. Don't miss the chance to be part of our expansion and make your mark in regulatory services.

Position Details

• Title: Regulatory Affairs Specialist / Deputy PRRC
• Location: Germany
• Experience: 3+ years in MDR; proficiency in German required

Responsibilities

1. Perform duties as Person Responsible For Regulatory Compliance (PRRC) per MDR and IVDR.
2. Ensure manufacturer compliance with MDR and IVDR as QA / RA expert.
3. Prepare and review SOPs and compliance documents.
4. Act as contact for Notified Bodies / Authorities.
5. Support registration processes and conduct gap assessments.
6. Review technical files for EU compliance.
7. Deliver regulatory intelligence projects and provide analytics.
8. Prepare artefacts for project delivery.
9. Support PMS projects as PRRC.
10. Coordinate with cross-functional teams and clients.
11. Manage communications with manufacturers and authorities.
12. Oversee daily project operations and risk management.
13. Ensure proper archiving and support audits.
14. Develop project metrics and maintain project tools.
15. Support registration portals and ensure compliance in Europe and Switzerland.

Secondary Responsibilities

• Analyze regulations and develop regulatory strategies.
• Stay updated on regulatory changes in Europe.
• Participate in meetings and training activities.
• Manage projects and resolve conflicts.
• Translate strategy into regulatory programs.
• Achieve goals aligned with business needs.

Qualifications

• Bachelor's in Life Sciences, Engineering, or related fields.
• 3+ years in Regulatory Affairs for medical devices.
• PRRC qualifications (required).
• Formal qualification recognized in the EU or equivalent.
• At least one year in regulatory affairs or quality management related to EU medical device requirements.