Global Regulatory Affairs Manager Medical Devices

5 days ago

London, Greater London, United Kingdom Novartis Farmacéutica Full time
About the Role

Key Responsibilities:

  1. Develop and implement global medical device regulatory strategies to maximize business benefits while ensuring regulatory compliance.
  2. Lead and support global Regulatory Affairs Medical Device (RA MD) submission activities for assigned projects/products, identifying required documentation for timely global submissions.
  3. Author and/or review high-quality RA MD documentation for Health Authority submission, applying agreed RA MD Global regulatory strategies, current regulatory trends, and guidelines.
  4. Communicate RA MD regulatory strategies, risks, and key issues throughout the life cycle to project teams and stakeholders, representing the department in cross-functional project teams as needed.
  5. Lead, prepare, and communicate RA MD Risk Management Assessments, contingency plans, and lessons learned on major submissions, escalating as necessary.
  6. Initiate and lead Health Authority interactions and negotiations, setting objectives, preparing briefing books, coordinating rehearsals, and risk mitigation plans.
  7. Maintain a single point of contact with global Health Authorities.
Requirements:
  1. Proven experience in medical device & Drug/Device Combination Products regulatory affairs in the pharmaceutical and/or medical device industry.
  2. Strong knowledge and experience in medical device & Drug/Device Combination Products regulatory submissions and approval processes, with understanding of the product development life cycle.
  3. Ability to critically evaluate data from various sources, work in interdisciplinary teams, and prioritize activities, timelines, and workload.
  4. Excellent interpersonal skills and experience working in complex, cross-functional organizations.
  5. Fluency in English.
Commitment to Diversity & Inclusion:

Novartis Farmacéutica is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

  • Regulatory Affairs Specialist

    7 days ago

    London, Greater London, United Kingdom Austin Vita Full time

    About the RoleThis is a fantastic opportunity for a Regulatory Affairs Specialist to join Austin Vita, a global medical device manufacturer based in the South East. The position offers hybrid working (at least 2 days per week on site) and relocation for the right candidate.Key ResponsibilitiesSupport change management activities, collaborating with different...

  • Regulatory Affairs Manager

    7 days ago

    London, Greater London, United Kingdom Austin Vita Full time

    About the RoleThis is a fantastic opportunity for a Regulatory Affairs Specialist to join Austin Vita, a global medical device manufacturer based in the South East. The position offers hybrid working (at least 2 days per week on site) and relocation for the right candidate.Key ResponsibilitiesSupport change management activities, collaborating with different...

  • Regulatory Affairs Lead

    6 days ago

    London, Greater London, United Kingdom Parexel Full time

    About the RoleWe are seeking a highly skilled Regulatory Affairs Lead to join our team at Parexel. As a key member of our Regulatory Affairs department, you will play a critical role in ensuring the successful development and approval of our medical device and combination product portfolio.Key ResponsibilitiesDevelop and implement regulatory strategies for...

  • Regulatory Affairs Lead

    7 days ago

    London, Greater London, United Kingdom Parexel Full time

    About the RoleWe are seeking a highly skilled Regulatory Affairs Lead to join our team at Parexel. As a key member of our Regulatory Affairs department, you will play a critical role in ensuring the successful development and approval of our medical device and combination product portfolio.Key ResponsibilitiesDevelop and implement regulatory strategies for...

  • Regulatory Affairs Specialist

    1 week ago

    London, Greater London, United Kingdom Indegene Full time

    Job DescriptionIndegene is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a Medical Device Compliance Expert, you will be responsible for providing expert advice on UK Medical Device Promotion regulations to our team.Key Responsibilities:Provide guidance on standards pertaining to advertising and promotion of medical devices in...

  • Regulatory Affairs Specialist

    4 days ago

    London, Greater London, United Kingdom Indegene Full time

    Job DescriptionIndegene is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a Medical Device Consultant, you will be responsible for providing expert regulatory advice to our team and ensuring client project requirements are met.Key Responsibilities:Provide guidance on UK medical device promotion regulations and standardsReview and...

  • Regulatory Affairs Specialist

    4 days ago

    London, Greater London, United Kingdom Indegene Full time

    Job DescriptionIndegene is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a Medical Device Consultant, you will be responsible for providing expert regulatory advice to our team and ensuring client project requirements are met.Key Responsibilities:Provide guidance on UK medical device promotion regulations and standardsReview and...

  • Regulatory Affairs Director

    6 days ago

    London, Greater London, United Kingdom Cpl Healthcare Full time

    Job Title: Regulatory Affairs Director - Medical DevicesJob Type: Full Time, Permanent PositionLocation: Remote or On-SiteRemuneration: Attractive salary and packageCpl Healthcare is seeking a highly experienced Regulatory Affairs Director to join our team. As a key member of our Medical Devices department, you will be responsible for the strategic lifecycle...

  • Regulatory Affairs Director

    6 days ago

    London, Greater London, United Kingdom Cpl Healthcare Full time

    Job Title: Regulatory Affairs Director - Medical DevicesJob Type: Full Time, Permanent PositionLocation: Remote or On-SiteRemuneration: Attractive salary and packageCpl Healthcare is seeking a highly experienced Regulatory Affairs Director to join our team. As a key member of our Medical Devices department, you will be responsible for the strategic lifecycle...

  • Regulatory Affairs Lead

    2 weeks ago

    London, Greater London, United Kingdom Austin Vita Full time

    Senior Regulatory Affairs SpecialistAustin Vita seeks a highly skilled Senior Regulatory Affairs Specialist to lead our Regulatory Affairs Team.Ensure medical device regulatory compliance with national and international legislation for projects, products, and new market clearance.Manage specific regulatory objectives to meet the company's Strategic Plan and...

  • Regulatory Affairs Specialist

    7 days ago

    London, Greater London, United Kingdom Indegene Full time

    Job DescriptionAbout UsWe are a leading technology-enabled healthcare solutions provider, driven by our purpose to empower healthcare organizations to be future-ready. We offer accelerated, global growth opportunities for talented professionals who are bold, industrious, and nimble. With Indegene, you gain a unique career experience that celebrates...

  • Medical Device Compliance Expert

    1 week ago

    London, Greater London, United Kingdom Indegene Full time

    Job DescriptionIndegene is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a Medical Device Compliance Expert, you will be responsible for providing expert advice on UK Medical Device Promotion regulations to our team.Key Responsibilities:Provide guidance on standards pertaining to advertising and promotion of medical devices in...

  • Regulatory Affairs Specialist

    4 days ago

    London, Greater London, United Kingdom Indegene Full time

    Job DescriptionAbout UsWe are a leading healthcare technology solutions provider, driven by our purpose to empower healthcare organizations to be future-ready. Our company offers accelerated, global growth opportunities for talented professionals who are bold, industrious, and nimble. With Indegene, you gain a unique career experience that celebrates...

  • Regulatory Affairs Specialist

    4 days ago

    London, Greater London, United Kingdom Indegene Full time

    Job DescriptionAbout UsWe are a leading healthcare technology solutions provider, driven by our purpose to empower healthcare organizations to be future-ready. Our company offers accelerated, global growth opportunities for talented professionals who are bold, industrious, and nimble. With Indegene, you gain a unique career experience that celebrates...

  • Associate Director, Regulatory Affairs

    4 weeks ago

    London, Greater London, United Kingdom Cpl Full time

    Job Title: Associate Director, Regulatory Affairs - Medical DevicesJob Type: Full Time, Permanent Position Location: Greater London, UK and some EU locations Remuneration: Attractive salary and packageAn exciting opportunity to join a growing pharmaceutical company that specialises in Cancer and Supportive Care, Gastroenterology and Hepatology. Due to...

  • Regulatory Affairs Specialist

    7 days ago

    London, Greater London, United Kingdom Indegene Full time

    Job DescriptionAbout UsIndegene is a technology-led healthcare solutions provider, driven by a purpose to enable healthcare organizations to be future-ready. We offer accelerated, global growth opportunities for talent that's bold, industrious, and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship, innovation,...

  • Regulatory Affairs Specialist

    4 days ago

    London, Greater London, United Kingdom Cure Talent Full time

    Cure Talent is excited to partner with a leading Medical Devices Manufacturer to fill an exciting opportunity for an experienced Regulatory Affairs Associate to join their team.As the new Regulatory Affairs Associate, you will be responsible for supporting global product registrations, maintaining design dossiers, and ensuring compliance with international...

  • Regulatory Affairs Specialist

    4 days ago

    London, Greater London, United Kingdom Cure Talent Full time

    Cure Talent is excited to partner with a leading Medical Devices Manufacturer to fill an exciting opportunity for an experienced Regulatory Affairs Associate to join their team.As the new Regulatory Affairs Associate, you will be responsible for supporting global product registrations, maintaining design dossiers, and ensuring compliance with international...

  • Regulatory Affairs Specialist

    4 days ago

    London, Greater London, United Kingdom Indegene Full time

    Job DescriptionAbout UsIndegene is a technology-led healthcare solutions provider, driven by a purpose to enable healthcare organizations to be future-ready. We offer accelerated, global growth opportunities for talent that's bold, industrious, and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship, innovation,...

  • Regulatory Affairs Specialist

    7 days ago

    London, Greater London, United Kingdom Indegene Full time

    Job DescriptionAbout UsIndegene is a technology-led healthcare solutions provider, driven by a purpose to enable healthcare organizations to be future-ready. We offer accelerated, global growth opportunities for talent that's bold, industrious, and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship, innovation,...