Associate Regulatory Affairs Specialist

4 months ago

Watford, United Kingdom Medtronic Full time

**Careers that Change Lives**
Support regulatory affairs field actions, provides support with addressing questions from the Competent Authority, Customers, Tenders, Marketing and Sales.
Support and advice the sales team to assure compliance with UK/I legislation applicable to i.e. Post Market Surveillance.

It is a hybrid position (2 days from office/3 days from home).

**A Day in the Life**
In close collaboration with other member of the Regulatory team, the main job duties are:

- FSCA: Prepares, executes and follows up of field safety corrective actions according enterprise plan. (Ensures update of the Medtronic reporting systems and record keeping in electronic databases). Close collaboration with the sales managers and sales reps. to collect/records evidence, allowing timely closure of the UK/I Field Actions
- Competent authorities Inquiries: Follow up on Inquiries from the Competent Authority to i.e., Field Action or Vigilance activities. This includes updating the Medtronic reporting systems and record keeping)
- Support on Post-Market Surveillance: Provide advisory to sales team members on product complaint handling processes and returns, to assure compliance to UK/I Regulations and Medtronic procedures.
- Monitors the shared mailbox and provides support to Tender Requests/ Customer Requests

**Must Haves**
- Advanced computer skills (Excel, Word, Smartsheet )
- Organizational & strong administrative skills
- Clear communication
- Quality orientation & patient safety focused
- Requires broad theoretical job knowledge typically obtained through advanced education

**Nice to Haves**
- Autonomy & proactivity, continuous learning, attention to details
- Enthusiastic, driven, innovative approach to business

**We Offer**
We offer a competitive salary and benefits package to all our employees:

- Flexible working environment
- Annual Incentive Plan % depending on company results
- Pension scheme and group discount on healthcare insurances
- Training possibilities via Cornerstone/Harvard Manage Monitor/GetAbstract
- Employee Assistance Program and Recognize (our global recognition program)

**About Medtronic**
Bold thinking. Bolder actions. We are Medtronic.
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world.
In everything we do, we are **engineering the extraordinary **.

**Our commitment**
Our unwavering commitment to inclusion, diversity, and equity (ID&E) means zero barriers to opportunity within Medtronic and a culture where all employees belong, are respected, and feel valued for who they are and the life experiences they contribute.
We know equity starts beyond our workplace, and we must play a role in addressing systemic inequities in our communities if we hope to have a long-term sustainable impact.
Anchored in our Mission, we continue to drive ID&E forward both to enhance the well-being of Medtronic employees and to accelerate innovation that brings our lifesaving technologies to more people in more places around the world.

**Your Answer

  • Regulatory Affairs Specialist

    1 month ago

    Watford, Hertfordshire, United Kingdom ENGINEERINGUK Full time

    About the RoleWe are seeking a highly skilled and experienced Regulatory Affairs Specialist to join our team. As a key member of our Regulatory Affairs team, you will play a critical role in ensuring that our operations are compliant with all relevant regulatory requirements.Key ResponsibilitiesLead the interpretation of new regulatory reporting...

  • Regulatory Affairs Specialist

    1 month ago

    Watford, Hertfordshire, United Kingdom ENGINEERINGUK Full time

    About the RoleWe are seeking a highly skilled and experienced Regulatory Affairs Specialist to join our team. As a key member of our Regulatory Affairs team, you will play a critical role in ensuring that our operations are compliant with all relevant regulatory requirements.Key ResponsibilitiesLead the interpretation of new regulatory reporting...

  • Regulatory Affairs Specialist

    2 weeks ago

    Watford, Hertfordshire, United Kingdom Medtronic Full time

    Unlock Your Potential at MedtronicAt Medtronic, we're driven by a passion to alleviate pain, restore health, and extend life. As a key member of our team, you'll have the opportunity to make a meaningful impact in the lives of millions of people worldwide.About the RoleWe're seeking an experienced Associate Regulatory Affairs Specialist to join our team in...

  • Regulatory Affairs Specialist

    2 weeks ago

    Watford, Hertfordshire, United Kingdom Medtronic Full time

    Unlock Your Potential at MedtronicAt Medtronic, we're driven by a passion to alleviate pain, restore health, and extend life. As a key member of our team, you'll have the opportunity to make a meaningful impact in the lives of millions of people worldwide.About the RoleWe're seeking an experienced Associate Regulatory Affairs Specialist to join our team in...

  • Regulatory Affairs Specialist

    2 weeks ago

    Watford, Hertfordshire, United Kingdom Medtronic Full time

    Unlock Your Potential at MedtronicAt Medtronic, we're driven by a passion to alleviate pain, restore health, and extend life. As a key member of our team, you'll have the opportunity to make a meaningful impact in the medical device industry.About the RoleWe're seeking an experienced Associate Regulatory Affairs Specialist to join our team in post-market...

  • Regulatory Affairs Specialist

    2 weeks ago

    Watford, Hertfordshire, United Kingdom Medtronic Full time

    Unlock Your Potential at MedtronicAt Medtronic, we're driven by a passion to alleviate pain, restore health, and extend life. As a key member of our team, you'll have the opportunity to make a meaningful impact in the medical device industry.About the RoleWe're seeking an experienced Associate Regulatory Affairs Specialist to join our team in post-market...

  • Regulatory Affairs Specialist

    3 weeks ago

    Watford, Hertfordshire, United Kingdom Medtronic Full time

    Unlock Your Potential at MedtronicAt Medtronic, we're driven by a passion to alleviate pain, restore health, and extend life. As a key member of our team, you'll play a vital role in championing healthcare access and equity for all.About the RoleWe're seeking an experienced Associate Regulatory Affairs Specialist to join our team. In this role, you'll be...

  • Regulatory Affairs Specialist

    3 weeks ago

    Watford, Hertfordshire, United Kingdom Medtronic Full time

    Unlock Your Potential at MedtronicAt Medtronic, we're driven by a passion to alleviate pain, restore health, and extend life. As a key member of our team, you'll play a vital role in championing healthcare access and equity for all.About the RoleWe're seeking an experienced Associate Regulatory Affairs Specialist to join our team. In this role, you'll be...

  • Regulatory Affairs Specialist

    2 weeks ago

    Watford, Hertfordshire, United Kingdom Medtronic Full time

    Unlock Your Potential at MedtronicAt Medtronic, we're driven by a passion to alleviate pain, restore health, and extend life. As a key member of our team, you'll play a vital role in championing healthcare access and equity for all.About the RoleWe're seeking an experienced Associate Regulatory Affairs Specialist to join our team. In this role, you'll be...

  • Regulatory Affairs Specialist

    2 weeks ago

    Watford, Hertfordshire, United Kingdom Medtronic Full time

    Unlock Your Potential at MedtronicAt Medtronic, we're driven by a passion to alleviate pain, restore health, and extend life. As a key member of our team, you'll play a vital role in championing healthcare access and equity for all.About the RoleWe're seeking an experienced Associate Regulatory Affairs Specialist to join our team. In this role, you'll be...

  • Regulatory Affairs Specialist

    1 week ago

    Watford, Hertfordshire, United Kingdom NEON HEALTHCARE LTD Full time

    Regulatory Affairs Compliance OfficerBackgroundNeon Healthcare is a dynamic and fast-growing pharmaceutical company that develops, produces, markets, and sells prescription-only medicines to hospitals, wholesalers, and retail pharmacies. Founded by entrepreneurs with a successful track record in building pharmaceutical businesses, the company has significant...

  • Pharmaceutical Regulatory Affairs Specialist

    60 minutes ago

    Watford, Hertfordshire, United Kingdom NEON HEALTHCARE LTD Full time

    Job DescriptionBackgroundAt Neon Healthcare, we are committed to developing and marketing innovative prescription only medicines to hospitals, wholesalers, and retail pharmacies. As a fast-growing pharmaceutical company, we are seeking a Regulatory Affairs Specialist to join our team and support the post-approval activities for our product portfolio.Key...

  • Regulatory Affairs Specialist

    5 days ago

    Watford, Hertfordshire, United Kingdom NEON HEALTHCARE LTD Full time

    Neon Healthcare is seeking a highly skilled Regulatory Affairs Officer to support the Regulatory team with post-approval activities for the product portfolio.Main Responsibilities:Maintain all aspects of the MAs registered particulars.Assist with the creation, collation, and publication of required documentation for the CTD dossier.Implement and communicate...

  • Regulatory Affairs Specialist

    6 days ago

    Watford, Hertfordshire, United Kingdom NEON HEALTHCARE LTD Full time

    Job DescriptionAt Neon Healthcare Ltd, we are seeking a highly skilled Regulatory Affairs Officer to support our Regulatory team with post-approval activities for our product portfolio.Main Responsibilities:Maintain all aspects of the MAs registered particulars.Assist with the creation, collation, and publication of required documentation for the CTD...

  • Regulatory Affairs Specialist

    1 week ago

    Watford, Hertfordshire, United Kingdom NEON HEALTHCARE LTD Full time

    Job SummaryNeon Healthcare Ltd is seeking a highly skilled Regulatory Affairs Officer to support the Regulatory team with post-approval activities for the product portfolio.This role requires a strong understanding of European and UK regulatory legislation and guidelines, as well as excellent communication and interpersonal skills.The successful candidate...

  • Regulatory Affairs Specialist

    7 days ago

    Watford, Hertfordshire, United Kingdom NEON HEALTHCARE LTD Full time

    Role OverviewAs a Regulatory Affairs Officer at Neon Healthcare, you will play a vital role in supporting the Regulatory team with post-approval activities for our product portfolio. This is an exciting opportunity to work with a fast-growing pharmaceutical company that develops, produces, markets, and sells prescription-only medicines to hospitals,...

  • Regulatory Affairs Manager

    3 weeks ago

    Watford, Hertfordshire, United Kingdom Allwyn UK Full time

    {"title": "Senior Manager, Regulatory Affairs", "description": "Join Allwyn UK's Regulatory Affairs TeamWe are seeking a highly skilled and experienced Senior Manager to lead our Regulatory Affairs team in navigating the new regulatory landscape of the National Lottery. As a key member of our team, you will play a critical role in ensuring that our...

  • Regulatory Affairs Manager

    3 weeks ago

    Watford, Hertfordshire, United Kingdom Allwyn UK Full time

    {"title": "Senior Manager, Regulatory Affairs", "description": "Join Allwyn UK's Regulatory Affairs TeamWe are seeking a highly skilled and experienced Senior Manager to lead our Regulatory Affairs team in navigating the new regulatory landscape of the National Lottery. As a key member of our team, you will play a critical role in ensuring that our...

  • Regulatory Affairs Manager

    4 weeks ago

    Watford, Hertfordshire, United Kingdom ENGINEERINGUK Full time

    Transform the National Lottery with UsWe're seeking a highly skilled Senior Manager to join our Regulatory Affairs team and help shape the future of the National Lottery. As a key member of our team, you'll play a crucial role in leading the implementation of our new regulatory model, ensuring compliance with the Fourth Licence and its obligations.About the...

  • Regulatory Affairs Manager

    4 weeks ago

    Watford, Hertfordshire, United Kingdom ENGINEERINGUK Full time

    Transform the National Lottery with UsWe're seeking a highly skilled Senior Manager to join our Regulatory Affairs team and help shape the future of the National Lottery. As a key member of our team, you'll play a crucial role in leading the implementation of our new regulatory model, ensuring compliance with the Fourth Licence and its obligations.About the...