Senior Regulatory Affairs Specialist

1 month ago

Crawley, West Sussex, United Kingdom Welland Medical Ltd Full time
About Us:

Welland Medical Ltd is a leading company in the healthcare and medical equipment industry, part of the Clinimed Holdings Limited group. With a rich history dating back to 1982, the group has grown through acquisitions and formations, establishing itself as a prominent player in the market.

We bring innovative products to market that enhance the lives of people living with a stoma worldwide. Our commitment to quality, safety, and customer satisfaction drives our business. We invest in talented people, collaborate to create groundbreaking products and services, and strive to make a positive impact in the world.

About the Job:

As a Senior Regulatory Affairs Specialist, you will play a pivotal role in supporting the business by developing regulatory strategies for new product development and registrations. You will manage the upkeep of all regulatory documentation and ensure that regulatory and standard changes are monitored and implemented as needed.

Main Duties & Responsibilities:
  • Lead a regulatory team of two, ensuring compliance with all relevant regulations and standards across the business.
  • Collaborate with regulatory authorities to achieve successful product registrations.
  • Develop and implement regulatory strategies for New Product Development (NPD) projects, from inception through Post-Market Surveillance, to ensure ongoing compliance and support product launches.
  • Oversee the maintenance of all regulatory documentation, including Clinical Evaluation Reports (CER), technical files, dossiers, and other regulatory submissions.
  • Provide regulatory support for sales and commercial activities, addressing customer and market authority inquiries and managing expectations.
  • Lead interactions with Notified Bodies on regulatory affairs (RA) matters.
  • Support all communications with regulatory authorities.
  • Lead regulatory transition projects and other significant regulatory initiatives.
  • Lead submission strategies for NPD projects and offer guidance on R&D product development.
  • Oversee regulatory decisions related to change control, assessing implications, approving or rejecting as appropriate, and maintaining accurate records of actions taken.
  • Support Quality Assurance (QA) in maintaining the Quality Management System (QMS) and Good Manufacturing Practice (GMP) certification, ensuring regulatory compliance across the organization.
  • Participate in auditing processes, providing regulatory guidance, and engaging in Notified Body audits.
  • Support vigilance reporting and Field Safety Corrective Actions (FSCA), liaising with regulatory authorities as needed.
  • Monitor and review changes in regulations and standards, assessing their impact on the business.
  • Ensure that Instructions for Use (IFUs), labelling, marketing materials, and technical documentation comply with relevant regulations and standards.
  • Create and maintain procedures to ensure ongoing regulatory compliance.
  • Advise and train colleagues on regulatory requirements, providing support to ensure full understanding and adherence.
  • Manage, support, and mentor the RA team.

  • Regulatory Affairs Specialist

    4 weeks ago

    Crawley, West Sussex, United Kingdom Nestlé SA Full time

    Regulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Nestlé SA. As a key member of our Regulatory Affairs team, you will play a pivotal role in ensuring the compliance of our products with UK and Irish regulations.Key Responsibilities:Review and ensure the accuracy and legal compliance of our labels...

  • Regulatory Affairs Specialist

    4 weeks ago

    Crawley, West Sussex, United Kingdom Nestlé SA Full time

    Regulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Nestlé SA. As a key member of our Regulatory Affairs team, you will play a pivotal role in ensuring the compliance of our products with UK and Irish regulations.Key Responsibilities:Review and ensure the accuracy and legal compliance of our labels...

  • Regulatory Affairs Specialist

    3 weeks ago

    Crawley, West Sussex, United Kingdom Nestle Operational Services Worldwide SA Full time

    Job Title: Regulatory Affairs SpecialistJob Summary:Nestle Operational Services Worldwide SA is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a Regulatory Affairs Specialist, you will play a pivotal role in ensuring our products comply with UK and Irish regulations.Key Responsibilities:Review and ensure the accuracy and legal...

  • Regulatory Affairs Specialist

    3 weeks ago

    Crawley, West Sussex, United Kingdom Nestle Operational Services Worldwide SA Full time

    Job Title: Regulatory Affairs SpecialistJob Summary:Nestle Operational Services Worldwide SA is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a Regulatory Affairs Specialist, you will play a pivotal role in ensuring our products comply with UK and Irish regulations.Key Responsibilities:Review and ensure the accuracy and legal...

  • Regulatory Affairs Specialist

    4 weeks ago

    Crawley, West Sussex, United Kingdom Nestle Operational Services Worldwide SA Full time

    Job Title: Regulatory Affairs SpecialistJob Summary:Nestle Health Science is seeking a highly skilled Regulatory Affairs Specialist to join our UK/I Regulatory Affairs team. As a key member of our team, you will be responsible for ensuring the accuracy and legal compliance of our labels and specifications, supporting the compilation of Medical Nutrition...

  • Regulatory Affairs Specialist

    4 weeks ago

    Crawley, West Sussex, United Kingdom Nestle Operational Services Worldwide SA Full time

    Job Title: Regulatory Affairs SpecialistJob Summary:Nestle Health Science is seeking a highly skilled Regulatory Affairs Specialist to join our UK/I Regulatory Affairs team. As a key member of our team, you will be responsible for ensuring the accuracy and legal compliance of our labels and specifications, supporting the compilation of Medical Nutrition...

  • Regulatory Affairs Specialist

    3 weeks ago

    Crawley, West Sussex, United Kingdom Nestlé SA Full time

    Regulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Nestlé SA. As a key member of our Regulatory Affairs team, you will play a pivotal role in ensuring our products comply with UK and Irish regulations.About the RoleYou will be responsible for reviewing recipes, raw materials, labelling, and...

  • Regulatory Affairs Specialist

    3 weeks ago

    Crawley, West Sussex, United Kingdom Nestlé SA Full time

    Regulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Nestlé SA. As a key member of our Regulatory Affairs team, you will play a pivotal role in ensuring our products comply with UK and Irish regulations.About the RoleYou will be responsible for reviewing recipes, raw materials, labelling, and...

  • Senior Regulatory Affairs Specialist

    1 month ago

    Crawley, West Sussex, United Kingdom Welland Medical Ltd Full time

    About UsWelland Medical Ltd is a leading company in the healthcare and medical equipment industry, part of the Clinimed Holdings Limited group. Founded in 1982, the group has a rich history of innovation and excellence.We bring to market the best and most innovative products that enhance the lives of people living with a stoma across the world. Our...

  • Senior Regulatory Affairs Specialist

    1 month ago

    Crawley, West Sussex, United Kingdom Welland Medical Ltd Full time

    About UsWelland Medical Ltd is a leading company in the healthcare and medical equipment industry, part of the Clinimed Holdings Limited group. Founded in 1982, the group has a rich history of innovation and excellence.We bring to market the best and most innovative products that enhance the lives of people living with a stoma across the world. Our...

  • Senior Regulatory Affairs Specialist

    1 month ago

    Crawley, West Sussex, United Kingdom Welland Medical Ltd Full time

    About UsWelland Medical Ltd is a leading company in the healthcare and medical equipment industry, part of the Clinimed Holdings Limited group. Founded in 1982, the group has a rich history of innovation and excellence.We are passionate about creating world-class products that enhance the lives of people living with a stoma. Our team is dedicated to...

  • Senior Regulatory Affairs Specialist

    1 month ago

    Crawley, West Sussex, United Kingdom Welland Medical Ltd Full time

    About UsWelland Medical Ltd is a leading company in the healthcare and medical equipment industry, part of the Clinimed Holdings Limited group. Founded in 1982, the group has a rich history of innovation and excellence.We are passionate about creating world-class products that enhance the lives of people living with a stoma. Our team is dedicated to...

  • Regulatory Affairs Specialist

    4 weeks ago

    Crawley, West Sussex, United Kingdom Nestlé SA Full time

    Regulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Nestlé SA. As a key member of our Regulatory Affairs team, you will play a pivotal role in ensuring the compliance of our products with UK and Irish regulations.About the RoleThe successful candidate will be responsible for reviewing recipes, raw...

  • Regulatory Affairs Specialist

    4 weeks ago

    Crawley, West Sussex, United Kingdom Nestlé SA Full time

    Regulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Nestlé SA. As a key member of our Regulatory Affairs team, you will play a pivotal role in ensuring the compliance of our products with UK and Irish regulations.About the RoleThe successful candidate will be responsible for reviewing recipes, raw...

  • Regulatory Affairs Specialist

    1 month ago

    Crawley, West Sussex, United Kingdom Nestle Operational Services Worldwide SA Full time

    Job Title: Regulatory Affairs SpecialistJob Summary:Nestle Health Science is seeking a highly skilled Regulatory Affairs Specialist to join our UK/I Regulatory Affairs team. As a key member of our team, you will be responsible for ensuring the accuracy and legal compliance of our labels and specifications, supporting the compilation of Medical Nutrition...

  • Regulatory Affairs Specialist

    1 month ago

    Crawley, West Sussex, United Kingdom Nestle Operational Services Worldwide SA Full time

    Job Title: Regulatory Affairs SpecialistJob Summary:Nestle Health Science is seeking a highly skilled Regulatory Affairs Specialist to join our UK/I Regulatory Affairs team. As a key member of our team, you will be responsible for ensuring the accuracy and legal compliance of our labels and specifications, supporting the compilation of Medical Nutrition...

  • Regulatory Affairs Specialist

    1 month ago

    Crawley, West Sussex, United Kingdom Nestlé SA Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Nestlé SA. As a key member of our Regulatory Affairs team, you will be responsible for ensuring that our products comply with all relevant regulations and laws.Your primary focus will be on reviewing and analyzing regulatory requirements, developing and implementing...

  • Regulatory Affairs Specialist

    1 month ago

    Crawley, West Sussex, United Kingdom Nestlé SA Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Nestlé SA. As a key member of our Regulatory Affairs team, you will be responsible for ensuring that our products comply with all relevant regulations and laws.Your primary focus will be on reviewing and analyzing regulatory requirements, developing and implementing...

  • Regulatory Affairs Specialist

    3 weeks ago

    Crawley, West Sussex, United Kingdom Nestlé SA Full time

    Job Title: Regulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Nestlé SA. As a key member of our Regulatory Affairs team, you will play a pivotal role in ensuring our products comply with UK and Irish regulations.About the RoleThe successful candidate will be responsible for reviewing recipes, raw...

  • Regulatory Affairs Specialist

    3 weeks ago

    Crawley, West Sussex, United Kingdom Nestlé SA Full time

    Job Title: Regulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Nestlé SA. As a key member of our Regulatory Affairs team, you will play a pivotal role in ensuring our products comply with UK and Irish regulations.About the RoleThe successful candidate will be responsible for reviewing recipes, raw...