Medical Device Regulatory Affairs Lead

2 months ago

London, United Kingdom Parexel Full time

When our values align, there's no limit to what we can achieve.
 

We are looking for a Regulatory Affairs Consultant - Medical Device Regulatory Lead for Alliance Combination Products will oversee key regulatory activities and report to the Global Device Regulatory Head for Alliance Combination Products, who in turn reports to the Head of GRA Device. In this role you will provide strategic and tactical support on combination product portfolio and will also have the opportunity to work on other innovative projects. You will work closely with key stakeholders including clinical, medical affairs, Industrial Affairs (Device Development, manufacturing, quality, supply chain) and drug product development. Combination product and drug delivery device systems technology is often exploring new territories that need “new” thinking and approaches from a regulatory perspective. You will be expected to proactively initiate discussions with regulatory authorities and contribute to industry standards and guidelines. This critical and highly visible position offers the successful candidate the opportunity to support a wide range of combination products, from pre-filled syringes, autoinjectors, pumps and other innovative combination product technologies, all of which are part of the exciting development pipeline. 

The role can be home or office based in various European locations.

Key Responsibilities

Serve as Device Regulatory Lead on complex and highly active combination product program teams (typically late stage and marketed products).

Develop innovative and sustainable medical device regulatory strategies covering combination products and delivery systems (device elements).

Provide regulatory guidance and advice to development teams.

Prepare regulatory design control deliverables.

Review and approve design control deliverables.

Lead and/or support global filing and lifecycle management activities for device aspects of combination product submissions.

Contribute to product development planning, including strategies to bridge delivery systems during development and post-approval changes.

Identify and manage issues and opportunities that impact submissions timelines; ensures appropriate communication, resolution and/or escalation as needed.

Ensure regulatory plans are monitored, progress/variance communicated to Management and any risks are highlighted.

Lead and/or support device related health authority interactions.

Provide regulatory impact assessments for proposed product changes.

Work closely with internal and external partners to ensure regulatory risks are identified, communicated, and properly addressed.

Contribute to internal regulatory processes and procedures for medical devices and combination products.

Engage with the relevant regulatory bodies and industry groups to influence industry standards and regulations, ensuring that the company’s best interests are represented.

Participate and contribute as a subject matter expert per regulatory roles and responsibilities relevant to the device regulatory lead position.

Skills and Qualifications:

University degree in a scientific or engineering discipline

At least 5 years of relevant medical device and/or combination product regulatory experience required.

Sound understanding of and experience with global regulatory requirements for combination products and drug delivery systems.

Working knowledge with technical/industry standards related to drug delivery systems, such as autoinjectors, pumps, etc.

Solid understanding of regulations and guidelines related to drug development and registration.

Proven experience in drug/device combination product regulatory approvals.

Demonstrate strategic thinking, initiative, change agent leadership and risk assessment proficiency, including ability to integrate overall business objectives into actionable project strategies.

Ability to synthesize and critically analyze data from multiple sources.

Strong interpersonal skills and the ability to deal effectively with a variety of business areas including medical, scientific, and manufacturing.

Demonstrates excellent communication and influencing skills internally and externally and in particular the ability to impact and influence decisions on global teams, both written and verbal, in English.

  • Regulatory Affairs Specialist

    6 days ago

    London Area, United Kingdom Indegene Full time

    About the RoleIndegene is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a Medical Device Regulatory Consultant, you will be responsible for providing expert regulatory advice to our clients and ensuring compliance with UK medical device regulations.Key ResponsibilitiesProvide guidance on UK medical device promotion regulations...

  • Associate Director, Regulatory Affairs

    5 days ago

    London, United Kingdom Cpl Healthcare Full time

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

  • Associate Director, Regulatory Affairs

    4 weeks ago

    London, United Kingdom Cpl Healthcare Full time

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

  • Associate Director, Regulatory Affairs

    5 days ago

    London, United Kingdom Cpl Healthcare Full time

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

  • Regulatory Affairs Lead

    5 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

    4 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

    5 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...

  • Associate Director, Regulatory Affairs

    1 month ago

    Greater London, United Kingdom Cpl Life Sciences Full time

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

  • Associate Director, Regulatory Affairs

    2 months ago

    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...

  • Global Regulatory Affairs Manager Medical Devices

    3 days ago

    London, Greater London, United Kingdom Novartis Farmacéutica Full time

    About the RoleKey Responsibilities:Develop and implement global medical device regulatory strategies to maximize business benefits while ensuring regulatory compliance.Lead and support global Regulatory Affairs Medical Device (RA MD) submission activities for assigned projects/products, identifying required documentation for timely global submissions.Author...

  • Global Regulatory Affairs Manager Medical Devices

    3 days ago

    London, Greater London, United Kingdom Novartis Farmacéutica Full time

    About the RoleKey Responsibilities:Develop and implement global medical device regulatory strategies to maximize business benefits while ensuring regulatory compliance.Lead and support global Regulatory Affairs Medical Device (RA MD) submission activities for assigned projects/products, identifying required documentation for timely global submissions.Author...

  • Regulatory Affairs Lead

    1 week 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 Manager

    5 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...

  • Medical Device Regulatory Consultant

    6 days ago

    London Area, United Kingdom Indegene Full time

    About the RoleIndegene is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a Medical Device Regulatory Consultant, you will be responsible for providing expert regulatory advice to our clients and ensuring compliance with UK medical device regulations.Key ResponsibilitiesProvide guidance on UK medical device promotion regulations...

  • Devices Regulatory Lead

    3 months ago

    London, United Kingdom Medicines and Healthcare products Regulatory Agency Full time

    We are currently looking for a **Devices Regulatory Lead **to join our **Software and AI** **Team within the **Healthcare Quality and Access** **group. This is a **full-time** opportunity, on a **12** month** fixed term contract/internal move or temporary promotion **basis. The role will be based in 10 South Colonnade, Canary Wharf London, E14 4PU. Please...

  • Regulatory Affairs Director

    4 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

    4 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 Specialist

    2 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

    2 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 Area, United Kingdom Indegene Full time

    About the RoleIndegene is seeking a highly skilled Regulatory Affairs Consultant to join our team. As a Regulatory Affairs Consultant, you will be responsible for providing expert guidance on UK Medical Device Promotion related Regulatory advice to our team.Key ResponsibilitiesProvide guidance on standards pertaining to advertising and promotion of medical...