Ingenieur Elektrotechnik und Reliability (m / w / d)

Novelis; Voerde (Niederrhein); Vor Ort; EUR 50.000 - 80.000; Vollzeit

Zusammenfassung

An innovative company is seeking a Regulatory Affairs Specialist to join their dynamic team. This role involves ensuring compliance with MDR and IVDR regulations, preparing essential compliance documents, and acting as a liaison with Notified Bodies. With a focus on regulatory excellence, you'll be part of a collaborative environment that values your expertise in navigating complex regulatory landscapes. If you're passionate about making a difference in the Life Sciences industry, this is your chance to contribute to impactful projects and help shape the future of regulatory services.

Qualifikationen

• 3+ years of experience in Regulatory Affairs for medical devices.
• PRRC qualifications as per EU requirements.

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 Affairs

MDR Compliance

IVDR Compliance

German Proficiency

Quality Assurance

Ausbildung

Bachelor's in Life Sciences

Bachelor's in Engineering

Bachelor's 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 are committed to excellence and innovation, assisting pharmaceutical, medical device, and biotech companies in navigating regulatory compliance.

Why Freyr?

At Freyr, we foster a collaborative and dynamic work environment that empowers our team. As we expand to Warsaw, Poland, we seek passionate and skilled 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 directly to this job post or visit our Careers page for more openings: https://www.freyrsolutions.com/careers/current-positions. Don't miss your chance to be part of our expansion and impact the world of regulatory services!

Position Details

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

Primary Responsibilities :

• Perform duties of Person Responsible For Regulatory Compliance (PRRC) per MDR and IVDR.
• Ensure manufacturer compliance with MDR and IVDR as QA / RA expert.
• Prepare and review SOPs and compliance documents.
• Act as contact for Notified Bodies / Authorities.
• Support registration processes and gap assessments.
• Review technical files for EU compliance.
• Deliver regulatory intelligence projects and interpret guidelines.
• Prepare artefacts for project delivery.
• Provide PMS support where responsible as PRRC.
• Coordinate technical inputs during client meetings.
• Liaise with internal and external stakeholders to monitor project progress.
• Manage communications with manufacturers and authorities.
• Oversee daily project operations and risk management.
• Ensure proper archiving and support audits.
• Develop project metrics and maintain project tools.
• Support database and registration portal maintenance in Europe.
• Ensure product compliance with MDR, IVDR, and other relevant regulations in Europe and Switzerland.

Secondary Responsibilities :

• Analyze regulations for compliance strategies.
• Stay updated on European regulatory landscape.
• Participate in meetings and training activities.
• Manage individuals and projects effectively.
• Resolve conflicts and translate strategies into regulatory programs.
• Achieve goals aligned with business needs.

Qualifications :

• Bachelor's in Life Sciences, Engineering, Pharmacy, or related field.
• 3+ years' experience in Regulatory Affairs for medical devices.
• PRRC qualifications as per EU requirements, with recognized qualifications.
• At least one year of relevant regulatory or quality management experience related to EU requirements.