Medical Device Compliance Manager

4 weeks ago

Windsor, United Kingdom InterSystems Full time

As a Medical Device Compliance Manager, you will play a critical role in maintaining and enhancing the compliance approach to ensure all our products and processes comply with regulatory requirements, standards, and guidelines related to medical devices.  You will be responsible for reviewing, assessing, and resolving issues relating to our device manufacture and implementation strategies. 

The oversight of the compliance aspects of product development, implementation and support, regulatory submissions, and medical device quality management systems are managed by a global compliance team, and this role is a key stakeholder in that.

This role will be office based in Windsor 5 days per week for the first 3 months and then revert to a hybrid model of 3 days office based in Windsor per week.

Role Responsibilities

  • Support the development and maintenance of regulatory compliance strategies for our medical device software products.
  • Ensure that all medical devices (including products that can be marketed as medical device) are assessed for relevant regulatory compliance.
  • Provide guidance and support to product development teams on regulatory requirements and compliance best practices.
  • Collaborate with cross-functional teams to integrate compliance considerations into product design and development processes.
  • Liaise with regulatory agencies and notified bodies to ensure timely and successful product registrations and submissions.
  • Monitor and track changes in regulations and standards that may impact our products and processes.
  • Monitor and track changes in regulations and standards that may impact our products and processes.
  • Manage relationships with external consultants and advisors to support compliance activities.
  • Lead and participate in internal audits and assessments to ensure compliance with relevant regulations and standards and identify and address potential gaps and opportunities for improvements.
  • Provide guidance and training to team members on compliance matters.
  • Stay up-to-date with evolving regulations and industry trends related to medical device compliance.
  • Liaise with regulatory agencies and notified bodies as necessary.

Required Skills and Experience

  • Bachelor's degree in a relevant field e.g., Bio-engineering, Life Sciences, Regulatory affairs or  related discipline. Masters degree preferred.
  • 5-10 years’ experience in medical device compliance, with expertise in software compliance.
  • Strong knowledge of global medical device regulations, such as FDA, EU MDR, ISO , DCB and other relevant standards.
  • Excellent communication, interpersonal and research skills.
  • Ability to work independently and collaboratively in a fast-paced environment with cross-functional teams and external partners.
  • Detail-oriented with a strong commitment to quality and compliance.
  • Prior experience interacting with regulatory agencies and notified bodies.

As an equal opportunities employer, InterSystems does not condone discrimination on the basis of age, disability, sex, sexual orientation, pregnancy and maternity, race or ethnicity, religion or belief, gender identity, or marriage and civil partnership.

We aspire to have a diverse and inclusive workplace and strongly encourage suitably qualified applicants from a wide range of backgrounds to apply and join our organisation.

  • Medical Device Compliance Specialist

    1 week ago

    Windsor, Windsor and Maidenhead, United Kingdom InterSystems Full time

    Job SummaryWe are seeking a highly skilled Medical Device Compliance Manager to join our team at InterSystems. As a key member of our global compliance team, you will play a critical role in maintaining and enhancing our compliance approach to ensure all our products and processes comply with regulatory requirements, standards, and guidelines related to...

  • Medical Device Specialist

    5 days ago

    Windsor, Windsor and Maidenhead, United Kingdom CV Library Full time

    Job SummaryWe are seeking a highly skilled Field Service Engineer to join our team at CV Library. As a Field Service Engineer, you will be responsible for servicing and maintaining a range of electro-mechanical medical devices across your region.Key ResponsibilitiesService and maintain electro-mechanical equipmentService and maintain electronic...

  • Medical Director

    14 hours ago

    Windsor, Windsor and Maidenhead, United Kingdom Pharma Partners Recruitment Ltd Full time

    Job DescriptionMedical Director UK and IrelandPharma-Partners Recruitment Ltd is currently supporting a specialist, global pharmaceutical company looking to hire a new Medical Director to lead their medical affairs function and be part of the strategic senior leadership team. As the Medical Director, you will play a pivotal role in shaping the company's...

  • Medical Director

    10 hours ago

    Windsor, Windsor and Maidenhead, United Kingdom Pharma Partners Recruitment Ltd Full time

    Job DescriptionMedical Director UK and IrelandPharma-Partners Recruitment Ltd is currently supporting a specialist, global pharmaceutical company looking to hire a new Medical Director to lead their medical affairs function and be part of the strategic senior leadership team. As the Medical Director, you will play a pivotal role in shaping the company's...

  • Medical Director

    12 hours ago

    Windsor, Windsor and Maidenhead, United Kingdom Pharma Partners Recruitment Ltd Full time

    Job OpportunityMedical Director UK and IrelandPharma-Partners Recruitment Ltd is currently supporting a specialist, global pharmaceutical company looking to hire a new Medical Director to lead their medical affairs function and be part of the strategic senior leadership team. As the Medical Director, you will play a pivotal role in shaping the company's...

  • Medical Director

    8 hours ago

    Windsor, Windsor and Maidenhead, United Kingdom Pharma Partners Recruitment Ltd Full time

    Job OpportunityMedical Director UK and IrelandPharma-Partners Recruitment Ltd is currently supporting a specialist, global pharmaceutical company looking to hire a new Medical Director to lead their medical affairs function and be part of the strategic senior leadership team. As the Medical Director, you will play a pivotal role in shaping the company's...

  • Medical Director

    16 hours ago

    Windsor, Windsor and Maidenhead, United Kingdom Pharma Partners Recruitment Ltd Full time

    Job Summary:The Pharma-Partners Recruitment Ltd is seeking a highly experienced and skilled Medical Director to lead their medical affairs function and be part of the strategic senior leadership team. As the Medical Director, you will play a pivotal role in shaping the company's medical strategy and ensuring compliance with industry regulations.Key...

  • Medical Director

    13 hours ago

    Windsor, Windsor and Maidenhead, United Kingdom Pharma Partners Recruitment Ltd Full time

    Job Summary:The Pharma-Partners Recruitment Ltd is seeking a highly experienced and skilled Medical Director to lead their medical affairs function and be part of the strategic senior leadership team. As the Medical Director, you will play a pivotal role in shaping the company's medical strategy and ensuring compliance with industry regulations.Key...

  • Medical Director

    2 days ago

    Windsor, United Kingdom Pharma Partners Recruitment Ltd Full time

    Medical Director UK and IrelandPharma-Partners is currently supporting a specialist, global pharma company looking to hire a new Medical Director to lead their medical affairs function and be part of the strategic senior leadership team. As the Medical Director, you will play a pivotal role in shaping the companies medical strategy and ensuring compliance...

  • Medical Director

    1 day ago

    Windsor, United Kingdom Pharma Partners Recruitment Ltd Full time

    Medical Director UK and Ireland Pharma-Partners is currently supporting a specialist, global pharma company looking to hire a new Medical Director to lead their medical affairs function and be part of the strategic senior leadership team. As the Medical Director, you will play a pivotal role in shaping the companies medical strategy and ensuring compliance...

  • Medical Director

    1 day ago

    Windsor, United Kingdom Pharma Partners Recruitment Ltd Full time

    Medical Director UK and IrelandPharma-Partners is currently supporting a specialist, global pharma company looking to hire a new Medical Director to lead their medical affairs function and be part of the strategic senior leadership team. As the Medical Director, you will play a pivotal role in shaping the companies medical strategy and ensuring compliance...

  • Medical Director

    2 days ago

    Windsor, United Kingdom Pharma Partners Recruitment Ltd Full time

    Medical Director UK and IrelandPharma-Partners is currently supporting a specialist, global pharma company looking to hire a new Medical Director to lead their medical affairs function and be part of the strategic senior leadership team. As the Medical Director, you will play a pivotal role in shaping the companies medical strategy and ensuring compliance...

  • Medical Director

    23 hours ago

    Windsor, United Kingdom Pharma Partners Recruitment Ltd Full time

    Medical Director UK and IrelandConsidering applying for this job Do not delay, scroll down and make your application as soon as possible to avoid missing out.Pharma-Partners is currently supporting a specialist, global pharma company looking to hire a new Medical Director to lead their medical affairs function and be part of the strategic senior leadership...

  • Medical Director

    2 days ago

    Windsor, United Kingdom Pharma Partners Recruitment Ltd Full time

    Medical Director UK and IrelandConsidering applying for this job Do not delay, scroll down and make your application as soon as possible to avoid missing out.Pharma-Partners is currently supporting a specialist, global pharma company looking to hire a new Medical Director to lead their medical affairs function and be part of the strategic senior leadership...

  • Medical Affairs Advisor

    3 months ago

    Windsor, United Kingdom Bial Full time

    **The Position** Reporting to the Director, Medical Affairs - UK & ROI, the Medical Affairs Advisor will work cross-functionally to support the development and execution of BIAL’s medical strategy and tactics, and ensure they reflect the needs of the UK market aligned to the brand strategy in line with the medical budget. **Duties and...

  • Medical Director

    1 day ago

    Windsor, Windsor and Maidenhead, United Kingdom Pharma Partners Recruitment Ltd Full time

    Job Summary:Pharma Partners Recruitment Ltd is seeking a highly experienced Medical Director to lead the medical affairs function and be part of the strategic senior leadership team for a global pharmaceutical company. As the Medical Director, you will play a pivotal role in shaping the company's medical strategy and ensuring compliance with industry...

  • Medical Director

    1 day ago

    Windsor, Windsor and Maidenhead, United Kingdom Pharma Partners Recruitment Ltd Full time

    Job Summary:Pharma Partners Recruitment Ltd is seeking a highly experienced Medical Director to lead the medical affairs function and be part of the strategic senior leadership team for a global pharmaceutical company. As the Medical Director, you will play a pivotal role in shaping the company's medical strategy and ensuring compliance with industry...

  • Quality Compliance Specialist

    1 day ago

    Windsor, Windsor and Maidenhead, United Kingdom GenesisCare Full time

    About the RoleWe are seeking a highly skilled Quality Compliance Specialist to join our team at GenesisCare UK. As a Quality Compliance Specialist, you will play a pivotal role in ensuring the delivery of high-quality services within our organization.Key ResponsibilitiesRegularly assess compliance with quality policies and procedures by managing clinical...

  • Quality Compliance Specialist

    2 days ago

    Windsor, Windsor and Maidenhead, United Kingdom GenesisCare Full time

    About the RoleWe are seeking a highly skilled Quality Compliance Specialist to join our team at GenesisCare UK. As a Quality Compliance Specialist, you will play a pivotal role in ensuring the delivery of high-quality services within our organization.Key ResponsibilitiesRegularly assess compliance with quality policies and procedures by managing clinical...

  • Quality Compliance Coordinator

    2 days ago

    Windsor, United Kingdom GenesisCare Full time

    At GenesisCare we want to hear from people who are as passionate as we are about innovation and working together to drive better life outcomes for patients around the world. Are you ready to embark on an exciting journey as a Quality Compliance Coordinator at our state-of-the-art cancer care centre located in Windsor? Join our dedicated team at GenesisCare...