Senior Expert Regulatory Affairs (m/f/x)

ZEISS Group; Aalen; Vor Ort; EUR 60.000 - 90.000; Vollzeit

Zusammenfassung

A leading manufacturer of medical devices is looking for a Senior Expert in Regulatory Affairs to develop and implement global regulatory pathways. This role emphasizes compliance and requires strong experience in regulatory affairs, quality management, and proficiency in English and German. The candidate will need to lead approval efforts while maintaining regulatory documentation according to quality management systems. This position is based in Aalen, Germany and offers a dynamic work environment.

Qualifikationen

• Strong experience in regulatory affairs and quality management, preferably in medical devices.
• Understanding of regulatory requirements and processes in relevant markets.
• Experience with FDA requirements and successful submissions, including digital processes.

Aufgaben

• Develop and implement global regulatory pathways for product authorizations.
• Ensure compliance of all products throughout their lifecycle.
• Lead efforts to obtain necessary approvals and licenses in various markets.

Kenntnisse

Regulatory affairs experience

Quality management skills

Project management skills

Analytical skills

Fluency in English

Fluency in German

Ausbildung

BS/MSc in Life Sciences, Engineering, or Regulatory Affairs

Tools

ISO 13485

MDSAP

Regulatory software

Jobbeschreibung

Your Talent, our Vision – together we see beyond. Your start at ZEISS Vision Care. As a leading manufacturer of ophthalmic lenses, we help people around the world achieve a clearer vision – sustainable and with focus on the future.

Our products are as diverse as the career paths we offer, from tailored lenses to award-winning measurement systems. Become part of our team and shape a future in which clear vision and professional success go hand in hand.

Your Role

As Senior Expert Regulatory Affairs you will be part of Regulatory Affairs team with the following responsibilities:

• Develop and implement global regulatory pathways for product authorizations

• Oversee preparation and submission of regulatory documents to authorities

• Ensure compliance of all products throughout their lifecycle, from authorization to discontinuation and ensure regulatory compliance for product labeling and support clinical trials

• Lead efforts to obtain necessary approvals and licenses in various markets (e.g., EU MDR, UK MDR)

• Integrate regulatory elements into business processes to minimize approval delays and rejections

• Maintain and update regulatory documentation related to Quality Management Systems and assess marketing claims

Your Profile

• BS/MSc in Life Sciences, Engineering, Optics, Regulatory Affairs and/or related experience

• Strong experience in regulatory affairs and quality management, preferably in medical devices, ideally with experience in standalone or embedded medical device software and IEC 62304, or in pharma

• Understanding and proven track record working with notified bodies and regulatory authorities in Europe

• Strong knowledge of regulatory requirements and processes in relevant markets combined with advanced project management skills, time and budget management proficiency in an multicultural environment

• Certifications in ISO 134485, MDSAP, PRRC, any other certification related to Life Science/Regulatory affairs is a plus

• Experience with FDA requirements and successful submissions (e.g., 510(k) and FDA audits) in addition to knowledge regarding digital processes in RA (incl. submissions, digitalization and intelligence)

• Strong analytical and problem-solving skills as well as a solid customer and result oriented focus

• Excellent communication and negotiation skills expressed with fluency in English and German

Your ZEISS Recruiting Team:

Hannah Beutler