Carl Zeiss Meditec AG
Regulatory Affairs Manager, Fokus Surgical Posterior Segment(m/w/x)
Full-timeOn-siteExperienced
Oberkochen
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CACarl Zeiss Vision International GmbH
Senior Expert Regulatory Affairs(m/w/x)
Aalen
Full-timeOn-siteManagement
Nejo AI Summary
Global regulatory pathways for ophthalmic lenses and medical device software. Experience with medical device software (IEC 62304) or pharma regulations, plus EU notified bodies, required. Work in multicultural environment.
Requirements
- BS/MSc in Life Sciences, Engineering, Optics, Regulatory Affairs, 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 a multicultural environment
- Certifications in ISO 13485, MDSAP, PRRC, or 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
Tasks
- Develop global regulatory pathways for product authorizations
- Prepare and submit regulatory documents to authorities
- Ensure product compliance throughout their lifecycle
- Maintain regulatory compliance for product labeling
- Support clinical trials with regulatory guidance
- Lead efforts to obtain approvals and licenses in various markets
- Integrate regulatory elements into business processes
- Maintain and update regulatory documentation for Quality Management Systems
- Assess marketing claims for regulatory compliance
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- ISO 13485
- MDSAP
- PRRC
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Carl Zeiss Vision International GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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CACarl Zeiss Vision International GmbH
Senior Expert Regulatory Affairs(m/w/x)
Aalen
Full-timeOn-siteManagement
Nejo AI Summary
Global regulatory pathways for ophthalmic lenses and medical device software. Experience with medical device software (IEC 62304) or pharma regulations, plus EU notified bodies, required. Work in multicultural environment.
Requirements
- BS/MSc in Life Sciences, Engineering, Optics, Regulatory Affairs, 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 a multicultural environment
- Certifications in ISO 13485, MDSAP, PRRC, or 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
Tasks
- Develop global regulatory pathways for product authorizations
- Prepare and submit regulatory documents to authorities
- Ensure product compliance throughout their lifecycle
- Maintain regulatory compliance for product labeling
- Support clinical trials with regulatory guidance
- Lead efforts to obtain approvals and licenses in various markets
- Integrate regulatory elements into business processes
- Maintain and update regulatory documentation for Quality Management Systems
- Assess marketing claims for regulatory compliance
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- ISO 13485
- MDSAP
- PRRC
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Carl Zeiss Vision International GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
Carl Zeiss Vision International GmbH
Industry
Manufacturing
Description
The company is a leading manufacturer of ophthalmic lenses, helping people achieve clearer vision sustainably.
Not a perfect match?
- Carl Zeiss Meditec AG
Regulatory Affairs Manager, Fokus Surgical Posterior Segment(m/w/x)
Full-timeOn-siteExperiencedOberkochen - Carl Zeiss Vision International GmbH
Head of Quality and Regulatory(m/w/x)
Full-timeOn-siteManagementAalen - Carl Zeiss Meditec AG
Regulatory Affairs Manager(m/w/x)
Full-timeTemporary contractOn-siteJuniorOberkochen - Carl Zeiss Meditec AG
Manager Labeling & Regulatory Projects(m/w/x)
Full-timeOn-siteExperiencedOberkochen - Carl Zeiss Meditec AG
Clinical Affairs Manager Microsurgery (MCS)(m/w/x)
Full-timeOn-siteExperiencedOberkochen