Senior Regulatory Affairs Manager
4 settimane fa
Job Type: Full Time, Permanent Position
Location: Italy (Milan) – Hybrid
Remuneration: Attractive salary and package
Cpl Healthcare is seeking a Senior Regulatory Affairs Manager to join our team. As a key member of our Regulatory Affairs department, you will be responsible for the strategic lifecycle management of our Medical Device portfolio.
Main Responsibilities:
- Be the primary regulatory point of contact for all medical device queries, providing guidance on regulatory medical device requirements and compliance to brand teams and other areas of the business.
- Lead and support all post-market surveillance activities for the medical device portfolio in the UK, Europe, and growth regions.
- Drive all Regulatory Affairs Medical Device strategies for global regions.
- Oversee, manage, and advise the Regulatory Service Provider on medical device maintenance and submission strategies, plans, and the preparation of updates to the technical file and regulatory submissions for all medical device-related changes.
- Prepare high-quality documentation for labelling regulatory submissions, following current best practices.
- Represent Regulatory Affairs Lifecycle Management – Medical Devices internally and externally.
- Maintain up-to-date knowledge of relevant regulations, guidelines, and industry standards and apply in practice through procedures, knowledge sharing, and advice to project teams.
- Manage regulatory intelligence information for medical devices, including databases (e.g., NOTIS).
- Coordinate QMS-related regulatory activities e.g., deviations and CAPAs as applicable.
- Manage own workload, including responsible delegation, to ensure agreed regulatory activities are planned, agreed, and progressed.
Requirements:
- BS, BSc, MS, MSc, PhD, PharmD, J.D., M.D. in science or healthcare preferred or equivalent relevant experience.
- Previous experience in Regulatory Affairs is a MUST.
- At least 8 years of experience within the medical device sector with a sound understanding of new registrations and post-market surveillance activities.
- Confident with maintaining medical devices in global regions.
- Broad regulatory medical device experience, part of which should have been gained operating at a senior level, and good knowledge of worldwide regulatory requirements (including GMP, GLP, and BCP).
- Must have expertise in the development, certification, and maintenance of medical device products.
- Line management or staff oversight/coaching experience.
- Experience managing Service Providers is essential.
This role allows the right person to step into a senior role within the business and take responsibility for a growing portfolio of medical devices. Due to the business's continuous growth, this person will have an excellent opportunity to grow and develop. The position also comes with an attractive salary and package.
-
Regulatory Affairs Specialist
3 settimane fa
Milano, Lombardia, Italia Hover Senior Living Community A tempo pienoJob SummaryThe Regulatory Affairs Senior Specialist will be supporting the implementation, execution and management of the local regulatory activities in Italy ensuring regulatory compliance with local regulatory requirements and corporate policies.The Regulatory Affairs Senior Specialist supports interactions with the national Regulatory Authorities, i.e....
-
Regulatory Affairs Manager
3 settimane fa
Milano, Lombardia, Italia W Executive S.R.L. A tempo pienoJob Description: We are seeking a highly skilled Regulatory Affairs Manager to join our team at W Executive S.R.L. The successful candidate will be responsible for ensuring that all our products meet the relevant government legislation and regulations, while prioritizing patient safety and efficacy. The main responsibilities of this role include:Managing the...
-
Regulatory Affairs Specialist
4 settimane fa
Milano, Lombardia, Italia W EXECUTIVE S.R.L. A tempo pienoJob Title: Regulatory Affairs ManagerCompany: W EXECUTIVE S.R.L.Location: MilanoAs a Regulatory Affairs Manager at W EXECUTIVE S.R.L., you will be responsible for ensuring that our company's products comply with all relevant laws and regulations. This includes developing and executing regulatory strategies, managing product registrations, and providing...
-
Senior Regulatory Affairs Expert
3 settimane fa
Milano, Lombardia, Italia Cpl Healthcare A tempo pienoJob Title: Associate Director, Regulatory Affairs - Medical Device/Post Market SurveillanceAbout the Role:As a key member of our Regulatory Affairs team, you will be responsible for the strategic lifecycle management of our Medical Devices. This includes oversight of all activities required for the successful and smooth integration of new products following...
-
Regulatory Affairs Director
3 settimane fa
Milano, Lombardia, Italia Cpl Healthcare A tempo pienoJob Title: Associate Director, Regulatory Affairs - Medical Device/Post Market SurveillanceJob Type: Full Time, Permanent PositionLocation: HybridRemuneration: Attractive salary and packageCpl Healthcare is seeking an experienced Associate Director, Regulatory Affairs - Medical Device Lifecycle Management to join their team. This role offers a unique...
-
Senior Regulatory Affairs Manager Medical Devices
3 settimane fa
Milano, Lombardia, Italia Cpl Healthcare A tempo pienoJob Title: Associate Director, Regulatory Affairs Medical Device Lifecycle ManagementJob Type: Full Time, Permanent PositionLocation: HybridRemuneration: Attractive salary and packageAbout the Role:We are seeking a highly experienced Associate Director, Regulatory Affairs Medical Device Lifecycle Management to join our team. As a key member of our Regulatory...
-
Regulatory Affairs Director
4 settimane fa
Milano, Lombardia, Italia Cpl Healthcare A tempo pienoJob Title: Associate Director, Regulatory Affairs - Medical Device/ Post Market SurveillanceJob Type: Full Time, Permanent PositionLocation: HybridRemuneration: Attractive salary and packageCpl Healthcare is seeking an experienced Regulatory Affairs Director to join their team. The ideal candidate will have a sound understanding of new registrations and...
-
Regulatory Affairs Expert
2 settimane fa
Milano, Lombardia, Italia The Kraft Heinz Company A tempo pienoJob Title: Regulatory Affairs ManagerJob Summary:We are seeking a highly skilled Regulatory Affairs Manager to join our team at The Kraft Heinz Company. As a Regulatory Affairs Manager, you will be responsible for ensuring all product labels used by Kraft Heinz in Europe comply with food legislation, government guidelines, and company policies, with a...
-
Regulatory Affairs Specialist
4 settimane fa
Milano, Lombardia, Italia W EXECUTIVE S.R.L. A tempo pienoJob DescriptionW EXECUTIVE S.R.L. is seeking a highly skilled Regulatory Affairs Manager to join our team. The successful candidate will be responsible for ensuring compliance with applicable laws, regulations, and standards.Main Responsibilities:Develop and execute regulatory strategies and plans to ensure compliance with applicable laws, regulations, and...
-
Regulatory Affairs Specialist
4 settimane fa
Milano, Lombardia, Italia W Executive S.R.L. A tempo pienoJob SummaryW Executive S.R.L. is seeking a highly skilled Regulatory Affairs Manager to join our team. The successful candidate will be responsible for developing and executing regulatory strategies and plans to ensure compliance with applicable laws, regulations, and standards.Main Responsibilities• Manage the registration of pharmaceutical products,...
-
Regulatory Affairs Director
3 settimane fa
Milano, Lombardia, Italia Parexel A tempo pienoRegulatory Affairs Director Job DescriptionWe are seeking a highly skilled and experienced Regulatory Affairs professional to lead our team's regulatory efforts. As a Director, you will be responsible for ensuring compliance with regulatory requirements and guidelines, providing guidance to project teams, and managing performance and development of staff...
-
Senior Regulatory Affairs Director for Medical Devices
2 settimane fa
Milano, Lombardia, Italia Cpl Healthcare A tempo pienoJob Title: Associate Director, Regulatory Affairs - Medical Device/Post Market SurveillanceJob Type: Full Time, Permanent PositionLocation: HybridRemuneration: Attractive salary and packageAn exciting opportunity to join a growing pharmaceutical company that specializes in Cancer and Supportive Care, Gastroenterology, and Hepatology. Due to increasing...
-
Regulatory Affairs Expert
4 settimane fa
Milano, Lombardia, Italia Parexel A tempo pienoUnlock Your Potential in Regulatory AffairsParexel, a leading Clinical Research Organization (CRO), is seeking a highly qualified Principal Regulatory Affairs Consultant (Associate Director level) with expertise in Chemistry, Manufacturing, and Controls (CMC) for small molecule. The ideal candidate will possess strong regulatory affairs experience, project...
-
Regulatory Affairs Specialist
3 settimane fa
Milano, Lombardia, Italia CooperCompanies A tempo pienoAbout CooperVisionCooperVision is one of the world's leading manufacturers of soft contact lenses with a presence in over 100 countries.As a Senior Regulatory Affairs Specialist at CooperVision, you will provide expert support and guidance to products from concept to launch.You will follow the company’s regulatory strategy for assigned corporate projects,...
-
Regulatory Affairs Manager
1 mese fa
Milano, Lombardia, Italia The Kraft Heinz Company A tempo pienoJob Title: Regulatory Affairs Manager - Infant and Medical FoodJob Summary:We are seeking a highly skilled Regulatory Affairs Manager to join our team in Milan. As a key member of our Legal, Government and Regulatory department, you will be responsible for ensuring compliance with food legislation and government guidelines for our Infant and Medical Food...
-
Regulatory Affairs Specialist
3 settimane fa
Milano, Lombardia, Italia Recordati A tempo pienoJob DescriptionRecordati is seeking a highly skilled Regulatory Affairs Specialist to join its international team. As a key member of the Corporate Regulatory Affairs department, you will be responsible for the management of regulatory activities for medicinal products for human use.Key Responsibilities:Preparation, review, and submission of relevant...
-
Regulatory Affairs Director
4 settimane fa
Milano, Lombardia, Italia Parexel A tempo pienoUnlock Your Potential as a Regulatory Affairs DirectorWe are seeking a highly skilled and experienced Regulatory Affairs Director to lead our team in the successful execution of multiple projects and ensuring client satisfaction. As a Director, you will be responsible for providing mentorship, leadership, and direction to Managers and consulting employees,...
-
Regulatory Affairs Manager
3 settimane fa
Milano, Lombardia, Italia The Kraft Heinz Company A tempo pienoAbout the RoleThe Kraft Heinz Company is seeking a highly skilled Regulatory Affairs Manager to join our Legal, Government and Regulatory Department.As a Regulatory Affairs Manager, you will be responsible for ensuring all product labels used by Kraft Heinz in Europe comply with food legislation, government guidelines and company policies, with a special...
-
Regulatory Affairs Director
4 settimane fa
Milano, Lombardia, Italia Parexel A tempo pienoUnlock Your Potential as a Regulatory Affairs DirectorWe are seeking a highly skilled and experienced Regulatory Affairs Director to lead our team in the successful execution of multiple projects and ensuring client satisfaction. As a Director, you will be responsible for providing mentorship, leadership, and direction to Managers and consulting employees,...
-
Compliance and Regulatory Affairs Manager
1 settimana fa
Milano, Lombardia, Italia 0896 Deutsche Bank Società per Azioni A tempo pienoDeutsche Bank Societa per Azioni is seeking a highly skilled Compliance and Regulatory Affairs Manager to join its team in Italy. The ideal candidate will have strong expertise in compliance, regulatory affairs, and risk management.Job Description:The successful candidate will be responsible for managing interactions with local and global regulators,...
