Quality Regulatory Affairs Strategist
vor 1 Monat
Transformative Impact in Skin Cancer Treatment
We are partnering with a pioneering MedTech company dedicated to revolutionising non-melanoma skin cancer (NMSC) treatment. Their non-invasive, painless solutions are transforming the field, and they're looking for an accomplished Quality & Regulatory Affairs Leader to lead their regulatory strategy in Munich, Germany.
About Metric Bio:
Metric Bio is a rapidly scaling business with immense growth opportunities. As a Senior Quality Manager, you will have the opportunity to join a high-impact team and shape regulatory pathways in Europe, Australia, South Africa, and the U.S., playing a vital role in making innovative treatments accessible globally.
Job Description:
You will develop and lead Quality System strategies to maintain and exceed regulatory compliance, mentor and guide junior team members, and direct end-to-end regulatory submissions for market approvals. You will act as the primary contact for regulatory bodies in Europe, the U.S., and other key regions, and prepare and empower teams for regulatory audits. Your goal will be to optimise and streamline quality and regulatory processes for efficient, global compliance.
Required Qualifications:
- Degree in engineering, biomedical sciences, or a related field (Master's or MBA is highly valued)
- 4+ years of hands-on experience in quality management and regulatory affairs for medical devices
- Demonstrated success in managing submissions, technical documentation, and market approvals (including MDD/MDR, De Novo, and 510(k) processes)
- In-depth knowledge of medical device QMS (ISO 13485 / 21 CFR 820) and experience leading audits with notified bodies
- Familiarity with essential standards such as ISO 14971, ISO 60601, or ISO 62366
Benefits:
The estimated salary for this position is €80,000 - €110,000 per year, depending on experience. Additionally, you can expect a comprehensive benefits package, including health insurance, retirement plan, and paid time off.
-
Munich, Bayern, Deutschland Metric Bio VollzeitAbout Metric BioMetric Bio is a pioneering MedTech company dedicated to revolutionising non-melanoma skin cancer (NMSC) treatment. Our innovative, non-invasive solutions are transforming the field, and we're seeking an accomplished Regulatory Affairs Strategist to lead our regulatory strategy in Munich, Germany. Salary: €120,000 - €150,000 per year Job...
-
Regulatory Affairs Director
vor 1 Monat
Munich, Bayern, Deutschland Metric Bio VollzeitJoin Metric Bio, a pioneering company in the field of skin cancer treatment, as a Senior Quality & Regulatory Affairs Leader.About Metric BioMetric Bio is transforming the landscape of skin cancer treatment with its innovative, non-invasive solutions. As a Senior Quality & Regulatory Affairs Leader, you will be part of a dynamic team shaping the future of...
-
Quality Assurance and Regulatory Affairs Manager
vor 4 Wochen
Munich, Bayern, Deutschland SciPro VollzeitCompany Overview:Scipro is a leading company in the fight against skin cancer, with innovative products launched in Europe, Australia, South Africa, and soon to be available in the US. To support their expansion, they are seeking a talented Quality Assurance and Regulatory Affairs Manager.Job Description:The successful candidate will maintain and oversee...
-
Regulatory Affairs Director
vor 4 Wochen
Munich, Bayern, Deutschland Metric Bio VollzeitMetric Bio Seeks Quality and Regulatory Affairs LeaderAre you a skilled professional looking to make a meaningful impact in the medical device industry? Metric Bio, a pioneering company in skin cancer treatment, is seeking an experienced Quality and Regulatory Affairs Leader to drive their regulatory strategy in Munich, Germany.About the RoleWe are seeking a...
-
Quality and Regulatory Affairs Manager
vor 2 Wochen
Munich, Bayern, Deutschland Danaher USA VollzeitAbout the Position:The Continuous Improvement Lead plays a critical role in driving improvement within QRA processes. This position requires a strong understanding of DBS, Lean, and continuous improvement principles, as well as experience in quality and regulatory affairs.Key Responsibilities:Establish and maintain DBS funnel for WITS QRASupport and develop...
-
Healthcare Technology Regulatory Affairs Specialist
vor 4 Wochen
Munich, Bayern, Deutschland ONCARE GmbH VollzeitWe are a dynamic and forward-thinking healthcare technology company, ONCARE GmbH, dedicated to transforming the healthcare market with our innovative platform, myoncare.As a Quality and Regulatory Affairs Manager, you will play a crucial role in ensuring compliance with regulatory requirements and maintaining the highest standards of quality for our...
-
Regulatory Affairs Manager
vor 3 Wochen
Munich, Bayern, Deutschland Triga Consulting GmbH & Co KG VollzeitSie suchen nach einer Herausforderung, die Ihre Fähigkeiten als Regulatory Affairs Manager auf die Probe stellt?ÜberblickEin international erfolgreiches Pharmaunternehmen mit marktführenden Produkten ist auf der Suche nach Verstärkung. Als Regulatory Affairs Manager werden Sie Teil eines dynamischen Teams und unterstützen den Erfolg des...
-
Senior Regulatory Affairs Specialist
vor 4 Wochen
Munich, Bayern, Deutschland SciPro VollzeitSciPro is a pioneering company in the fight against skin cancer, expanding its innovative products across Europe, Australia, South Africa, and soon to be launched in the US market. To support this growth, they are seeking a highly skilled Quality Assurance Manager.Key Responsibilities:Maintain and oversee compliance with quality systems, ensuring seamless...
-
Strategic Regulatory Affairs and Quality Manager
vor 3 Wochen
Munich, Bayern, Deutschland ONCARE GmbH VollzeitWe are innovators, driving forces and pathway makers in the healthcare industry. Our health platform myoncare is revolutionizing the market by connecting all players to ensure patients receive the right therapy at the right time.Our commitment is centered around people and their needs. We strive to provide excellent support for all patients worldwide by...
-
Regulatory Affairs Business Partner
vor 4 Wochen
Munich, Bayern, Deutschland Daiichi Sankyo Europe GmbH VollzeitAbout Daiichi Sankyo Europe GmbHWe are a leading pharmaceutical company with over 120 years of experience and a presence in over 20 countries. Our mission is to improve the quality of life by discovering, developing, and delivering innovative treatments.Role OverviewThe Compliance Officer (Business Partnering) will be responsible for supporting the...
-
Expert in ADAS and Regulatory Affairs
vor 4 Wochen
Munich, Bayern, Deutschland NIO VollzeitAbout NIO: A pioneer in premium smart electric vehicles, leading the industry with technological breakthroughs and innovations. Our mission is to shape the future of mobility.Job OverviewWe are seeking a highly skilled Regulatory Specialist/Expert ADAS&AD to join our team. As a key member of our regulatory affairs department, you will play a crucial role in...
-
Regulatory Affairs Manager
vor 4 Wochen
Munich, Bayern, Deutschland Triga Consulting GmbH & Co KG VollzeitBerufsbildAls Regulatory Affairs Manager übernehmen Sie die verantwortliche Betreuung von Verfahren in der Arzneimittelzulassung bei einem international erfolgreichen Pharmaunternehmen. Das Unternehmen ist marktführend und bietet innovative Produkte an.In dieser Position sind Sie direkt mit Zulassungsbehörden in Kontakt und haben Ansprechpartner für...
-
Munich, Bayern, Deutschland Vality One Recruitment GmbH VollzeitCompany OverviewVality One Recruitment GmbH is a leading global recruitment agency with a focus on international regulatory affairs.
-
Medical Devices Regulatory Compliance Specialist
vor 1 Monat
Munich, Bayern, Deutschland SciPro VollzeitAbout SciProSciPro is a fast-growing startup dedicated to fighting skin cancer with innovative products.Job OverviewThis role offers an exciting opportunity to maintain and oversee compliance with quality systems, optimize global QA/RA processes, and ensure regulatory requirements are met.Key ResponsibilitiesMaintain and improve compliance with quality...
-
Senior Medical Device Quality Manager
vor 4 Wochen
Munich, Bayern, Deutschland EPM Scientific VollzeitJob DescriptionEPM Scientific is seeking a highly experienced Senior Medical Device Quality Manager to join our team.Key Responsibilities:Develop and implement regulatory strategies for securing product approvals in the US and EU, ensuring compliance with FDA QSR and MDR regulations.Plan and manage audits conducted by notified bodies, regulatory authorities,...
-
Chief Quality Strategist
vor 4 Wochen
Munich, Bayern, Deutschland STABL Energy VollzeitAbout the RoleWe are seeking a highly experienced Chief Quality Strategist to join our team at STABL Energy. In this key role, you will play a pivotal part in shaping and implementing our quality strategy, fostering collaborative relationships with our engineering and operations teams.Key ResponsibilitiesDevelop and implement a comprehensive quality strategy...
-
Data Governance Strategist
vor 4 Wochen
Munich, Bayern, Deutschland State Street Corporation VollzeitAbout the RoleWe are seeking a seasoned professional to assume the role of Data Governance Strategist, focusing on ensuring BCBS 239 compliance and driving data quality initiatives within our organization. This position requires a strong understanding of regulatory requirements, excellent communication skills, and the ability to collaborate with...
-
Strategic International Regulatory Affairs Lead
vor 3 Wochen
Munich, Bayern, Deutschland Vality One Recruitment GmbH VollzeitJob DescriptionWe are seeking a highly skilled Strategic International Regulatory Affairs Lead to join our team at Vality One Recruitment GmbH. As a key member of our organization, you will be responsible for overseeing all approval processes in approximately 35 countries worldwide.Key ResponsibilitiesGlobal Approval Process Management: Ensure seamless...
-
Munich, Bayern, Deutschland TÜV SÜD VollzeitAbout TÜV SÜDTÜV SÜD is passionate about technology, driving innovations that impact our daily lives in countless ways. We test, audit, inspect, and advise to ensure the safety of society and its people. Our commitment to professional excellence and innovation makes us a leader in our field.Job SummaryWe are seeking a Senior Technical Compliance and...
-
Transformation Specialist
vor 2 Wochen
Munich, Bayern, Deutschland Danaher USA VollzeitAbout the Role:The Continuous Improvement Lead is a multifunctional position responsible for driving improvement within Quality and Regulatory Affairs (QRA) processes. The successful candidate will work closely with the VP Quality and Regulatory Affairs to establish and maintain the Danaher Business System (DBS) funnel for WITS QRA.Key responsibilities...