Regulatory Compliance Consultant (m/f/d)

bayoonet Aktiengesellschaft; Darmstadt; Vor Ort; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

bayoonet Aktiengesellschaft in Darmstadt is seeking a Regulatory Compliance Consultant to advise clients in the medical technology, pharmaceutical, and biotech sectors. You will support the development and market approval of complex products, including digital medical devices and drug combinations.

The ideal candidate has completed relevant studies and possesses sound regulatory knowledge. Strong communication skills in both German and English are essential.

Qualifikationen

• Sound knowledge of regulatory requirements for medical devices and/or medicinal products (MDR/IVDR, ISO 13485, 21 CFR, GxP).
• Experience in regulatory affairs or compliance consulting, ideally focused on combined products or digital medical technology.
• Business fluent in German and English.

Aufgaben

• Advise on regulatory requirements (MDR, IVDR and MDSAP countries).
• Support in the creation and maintenance of technical documentation for medical devices.
• Manage conformity assessment procedures for medical devices and combination products.
• Provide guidance for clinical trials within investigational product responsibility.
• Coordinate with customers, authorities, notified bodies and partners.
• Participate in and manage audits.
• Negotiate quality assurance contracts.

Kenntnisse

Regulatory knowledge (MDR, IVDR)

Communication skills

Analytical skills

Project management

Stakeholder management

Teamwork

Ausbildung

Completed studies in medical technology, natural sciences, pharmacy, law or similar

Jobbeschreibung

Regulatory Compliance Consultant (m/f/d)

You will advise both our internal teams and external customers from the medical technology, pharmaceutical and biotech sectors. In particular, you will support our clients in the development and market approval of complex products, digitally networked medical devices and combined medical device/drug combinations.

Your versatile field of activity includes, among other things

• Advice on regulatory requirements (MDR, IVDR, as well as the requirements of the MDSAP countries)
• Support in the creation and maintenance of technical documentation for medical devices in accordance with regulatory requirements
• Accompanying conformity assessment procedures – in particular for medical devices and combination products
• Advice and support for clinical trials within the scope of investigational product responsibility
• Stakeholder management and coordination with customers, authorities, notified bodies and partners
• Participation in and management of audits
• Negotiation of quality assurance contracts

Your profile

• Completed studies in a relevant field (medical technology, natural sciences, pharmacy, law or similar)
• Sound knowledge of regulatory requirements for medical devices and/or medicinal products (MDR/IVDR, ISO 13485, 21 CFR, GxP…)
• Experience in regulatory affairs or compliance consulting, ideally with a focus on combined products or digital medical technology
• Communication and consulting skills – both internally and externally towards customers
• Structured and analytical way of working as well as a high customer and result orientation
• Business fluent in German and English

In addition to your technical and practical know-how, you have a confident and empathetic manner. You are also characterized by social skills in the form of reliability, commitment and flexibility, and you demonstrate a high degree of independence as well as a strong ability to work in a team. Above all, you’re a thinker.