Senior Regulatory Affairs Specialist

TN Germany; Herzogenrath; Vor Ort; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

A leading biomedical company in Herzogenrath is seeking a Senior Regulatory Affairs Specialist to coordinate regulatory projects and ensure compliance with EU regulations. The ideal candidate will have a Master's degree and experience in medical technology. This role requires strong communication skills and the ability to work with regulatory agencies at both national and international levels.

Qualifikationen

• At least 3 years of experience as a Regulatory Affairs Specialist.
• Deep understanding of ISO standards and regulations.

Aufgaben

• Coordinate projects to implement new regulatory requirements.
• Assist in development projects related to Regulatory Affairs.
• Communicate with national and international Regulatory Agencies.

Kenntnisse

Regulatory Affairs

Communication

Project Management

Ausbildung

Master's degree in Biomedical Science

Master's degree in Chemistry

Master's degree in Pharmacy

Master's degree in Natural Science

Jobbeschreibung

Job Title: Senior Regulatory Affairs Specialist, Herzogenrath

Client:

Envista

Location:

Herzogenrath, Germany

Job Category:

Other

EU work permit required:

Yes

Job Reference:

82815cae7323

Job Views:

1

Posted:

14.05.2025

Expiry Date:

28.06.2025

Job Description:

Company Overview: Matricel GmbH, headquartered in Herzogenrath, Germany, was acquired by Nobel Biocare in 2020, part of Envista Holdings based in Brea, California, USA. Matricel is a rapidly growing biomedical company developing innovative medical devices for regenerative medicine.

Primary Duties & Responsibilities:

1. Coordinate projects to implement new regulatory requirements (e.g., EU MDR 2017/745) and support other departments in compliance efforts.
2. Assist in development projects related to Regulatory Affairs, including creating and editing technical documentation for medical devices.
3. Communicate with national and international Regulatory Agencies.
4. Develop and support regulatory strategies at national and international levels.
5. Initiate and manage projects to meet updated regulatory requirements ensuring market access.

Job Requirements:

1. Master's degree or equivalent in Biomedical Science, Chemistry, Pharmacy, Natural Science, or related field.
2. At least 3 years of experience as a Regulatory Affairs Specialist in medical technology, preferably with international exposure.
3. Deep understanding of standards and regulations such as ISO 13485, ISO 14971, 21 CFR Part 820, MDSAP, MDR, and international approval processes.
4. Experience with medical device registration in Japan is advantageous.
5. Ability to prepare and update regulatory plans and reports, including SSCP reports and PSURs, in compliance with MDR.
6. Fluent in English; proficiency in German is a plus.

Operating Company: Nobel Biocare

Note: Envista will not accept unsolicited resumes unless submitted directly by candidates or through approved agencies with prior written approval.