Core member of medical device and combination product development teams, providing high quality regulatory input to ensure that the developed product meets global Health Authority expectations
Primary point of contact for Notified Body and global Health Authorities for stand-alone medical device registrations and leadership of MDR Article 117 Notified Body Opinion interactions
Deliver high quality regulatory documents to support global Health Authority submissions for combination products and stand-alone medical devices
Supports audit readiness activities and inspections for medical devices and combination products including obtainment and maintenance of certification for stand-alone medical devices
Write and maintain high-quality regulatory documents and responses for Health Authorities and Notified Bodies according to established guidelines, processes, IT systems and SOPs, to ensure technical congruency and regulatory compliance while meeting agreed timelines and submission requirements
Regulatory lead for the development / manufacture of medical devices and combination products, including management of relevant registration, certification, and audit requirements
Operational owner of medical device and combination product related deliverables and timelines
Regulatory device lead for post approval phase, supporting global registrations, responsible for evaluation of changes, definition of implementation strategies and submission of variations
Strategic oversight of medical device and combination product regulatory activities – ability to lead others to ensure successful identification of device deliverables, completion of deliverables in-line with development milestones and successful integration into dossiers and successful response to health authority deficiency letters or requests for information
Requirements
Advanced University degree or equivalent education/degree in engineering or life science/healthcare is required (minimum requirement Masters degree or equivalent)
5+ year industry experience working in medical device/combination product development or registration with a solid grasp of relevant regulations and standards including MDR 2017/745, 21 CFR 820 / 21 CFR 4, ISO 13485 and ISO 11608
Proven track record of supporting development of medical devices or combination products starting from design planning through to design transfer
Experience in the generation of the technical file for stand-alone device submission or experience in the generation of Notified Body Opinions or relevant CTD modules for combination products including module 3 sections P2.4, P3.5 and P7
Experience in the generation or review of Clinical Evaluation Protocols and Reports for medical device submissions
Fluent in English (oral and written) – with excellent verbal and written communication skills
Ability to lead others to achieve results in a complex highly matrixed environment
Core Competencies Demonstrates expertise in regulatory affairs for medical devices and combination products, ensuring compliance with global Health Authority standards and leading successful submissions. Proven ability to manage complex regulatory processes, including Notified Body interactions and audit readiness.
Highest-signal resume keywords
Regulatory Affairs Expertise
MDR 2017/745 Compliance
ISO 13485 Knowledge
Technical File Generation
Clinical Evaluation Protocols
ATS Optimization Keywords Hard Skills
Regulatory Document Writing
Medical Device Registration
Combination Product Development
Audit Readiness
Submission Requirements Management
Health Authority Interaction
Design Transfer Support
Technical File Generation
Regulatory Compliance
Change Evaluation
Soft Skills
Leadership
Communication Skills
Collaboration
Problem-Solving
Matrix Management
Certifications & Qualifications
Advanced University Degree
Masters Degree in Engineering or Life Science
Industry Keywords
Medical Device Development
Combination Products
Notified Body
21 CFR 820
21 CFR 4
ISO 11608
Health Authority Submissions
Regulatory Input
Deficiency Letters
Submission Variations
#J-18808-Ljbffr
Primary point of contact for Notified Body and global Health Authorities for stand-alone medical device registrations and leadership of MDR Article 117 Notified Body Opinion interactions
Deliver high quality regulatory documents to support global Health Authority submissions for combination products and stand-alone medical devices
Supports audit readiness activities and inspections for medical devices and combination products including obtainment and maintenance of certification for stand-alone medical devices
Write and maintain high-quality regulatory documents and responses for Health Authorities and Notified Bodies according to established guidelines, processes, IT systems and SOPs, to ensure technical congruency and regulatory compliance while meeting agreed timelines and submission requirements
Regulatory lead for the development / manufacture of medical devices and combination products, including management of relevant registration, certification, and audit requirements
Operational owner of medical device and combination product related deliverables and timelines
Regulatory device lead for post approval phase, supporting global registrations, responsible for evaluation of changes, definition of implementation strategies and submission of variations
Strategic oversight of medical device and combination product regulatory activities – ability to lead others to ensure successful identification of device deliverables, completion of deliverables in-line with development milestones and successful integration into dossiers and successful response to health authority deficiency letters or requests for information
Requirements
Advanced University degree or equivalent education/degree in engineering or life science/healthcare is required (minimum requirement Masters degree or equivalent)
5+ year industry experience working in medical device/combination product development or registration with a solid grasp of relevant regulations and standards including MDR 2017/745, 21 CFR 820 / 21 CFR 4, ISO 13485 and ISO 11608
Proven track record of supporting development of medical devices or combination products starting from design planning through to design transfer
Experience in the generation of the technical file for stand-alone device submission or experience in the generation of Notified Body Opinions or relevant CTD modules for combination products including module 3 sections P2.4, P3.5 and P7
Experience in the generation or review of Clinical Evaluation Protocols and Reports for medical device submissions
Fluent in English (oral and written) – with excellent verbal and written communication skills
Ability to lead others to achieve results in a complex highly matrixed environment
Core Competencies Demonstrates expertise in regulatory affairs for medical devices and combination products, ensuring compliance with global Health Authority standards and leading successful submissions. Proven ability to manage complex regulatory processes, including Notified Body interactions and audit readiness.
Highest-signal resume keywords
Regulatory Affairs Expertise
MDR 2017/745 Compliance
ISO 13485 Knowledge
Technical File Generation
Clinical Evaluation Protocols
ATS Optimization Keywords Hard Skills
Regulatory Document Writing
Medical Device Registration
Combination Product Development
Audit Readiness
Submission Requirements Management
Health Authority Interaction
Design Transfer Support
Technical File Generation
Regulatory Compliance
Change Evaluation
Soft Skills
Leadership
Communication Skills
Collaboration
Problem-Solving
Matrix Management
Certifications & Qualifications
Advanced University Degree
Masters Degree in Engineering or Life Science
Industry Keywords
Medical Device Development
Combination Products
Notified Body
21 CFR 820
21 CFR 4
ISO 11608
Health Authority Submissions
Regulatory Input
Deficiency Letters
Submission Variations
#J-18808-Ljbffr
RA Manager – Regulatory Devices Arbeitgeber: Jobtailor
Als Global Director B2B – Business Development bei uns profitieren Sie von einer dynamischen und innovativen Arbeitsumgebung, die auf Zusammenarbeit und Kreativität setzt. Wir bieten Ihnen nicht nur attraktive Vergütungsmodelle und umfassende Weiterbildungsmöglichkeiten, sondern auch die Chance, in einem internationalen Team zu arbeiten, das Vielfalt und persönliche Entwicklung fördert. Unsere Unternehmenskultur legt großen Wert auf Flexibilität und Work-Life-Balance, sodass Sie Ihre Karriereziele in einem unterstützenden Umfeld erreichen können.
