Clinical Governance Lead (19827)

It's a really exciting time to be at Holland & Barrett. We are investing across all areas of our business with a vision of empowering our customers to live happier, healthier lives. Our mission is to be the leading player in global wellness chosen by millions as their trusted partner for personalised wellness journeys. To achieve this goal, we are embarking on a radical transformation. We are recruiting top talent in all areas of our business, from Finance to Digital Marketing, from HR to IT, as well as new functions around Health and Wellness.

Reporting to the Director of Science & Wellness, the Clinical Governance Lead will manage and maintain key clinical registrations and work with other H&B functions on clinical governance issues

Key Responsibilities: 

• Serve as a liaison with regulatory agencies pertaining to assigned products, services, or offerings.
• Assemble, prepare and submit original registrations, amendments, variations, maintenance reports, and other documents to regulatory agencies when applicable.
• Set up quality control measures and establish standard operating procedures and KPIs
• Develop risk management plans and mitigation strategies to ensure regulatory compliance
• Develop the regulatory risk assessment and risk mitigation plan for new propositions 

CQC registration

• • Support setting up the CQC registration process
  • Responsible for ongoing monitoring & maintenance of CQC registration
• Medical Device registration
  • Support setting up Medical Device registration process
  • Responsible for ongoing monitoring & maintenance of Medical Device registration
• Diagnostics/IVD
  • Work with Medical compliance team to conduct clinical due diligence & onboarding of new clinical partners
• New Propositions/ Partners
  • Conduct in-depth clinical due diligence on potential partners

Experience/Qualifications

• Master's degree in chemistry, biochemistry, pharmacology, or digital healthcare, health technology or any related health field.
• Senior Nurse, Pharmacist or any senior clinical quality and safety health professional with experience in managing clinical risk in healthcare (clinics, hospitals and digital)
• A track record of securing regulatory approval for medical devices and digital health software as Medical Device (SaMD)
• Knowledge of IVD regulations, device safety/drug safety (pharmacovigilance)
• Preferable to have prior experience in:
  • Risk management (developing risk management plans and mitigation strategies)
  • Accreditation of online consultations & health providers (including prior experience working with CQC)
• 8+ experience in clinical compliance and governance, safety and quality.

Experience in digital health or related industries, e.g., medical device, pharmaceutical, and FMCG industries is preferable. (external support can be sourced)

Cultural and personality fit will be crucial to success

• Strategic mindset as well as being a deep subject matter expert
• A strong influencer with great presentation skills who can quickly build trust and credibility
• Can thrive in an ambiguous and changing environment
• Collaborative style, a natural collaborator who seeks to engage, influence and work collaboratively with colleagues across H&B
• Integrity and strong professional conduct based on doing the right thing
• Able to demonstrate a continuous improvement mindset & commitment to improving processes.
• A strong communicator with the ability to present and bring people on the journey
• Excellent written and verbal communication skills, able to breakdown complex problems or solutions and articulate them in a compelling and simple way
• Team player with experience of breaking down silos and creating shared visions
• Energetic and enthusiastic, able to influence, inspire and encourage others within the business.

  Location:  Flexible - The company has a base in Nuneaton and an office in London and the candidate will be expected to travel to these location as required by the requirements and accountabilities of the role. We are a global, digitally enabled business and we expect our colleagues to be self-driven and to determine the most appropriate place to work each day to meet the requirements of the role, achieve their best performance and optimum output.

• Electric Car Scheme.
• Bonus up to 10%.
• Pension company contribution= 5%.
• Your wellbeing is paramount so you can get away and take 33 Days Holiday per year.
• Private Medical Care (Self)
• Learning and Development opportunity with Holland & Barrett is a great base for career development long term.
• Career progression.
• Refer and Earn Scheme- as we're growing you can earn money by referring people to join us from your network.
• Epic Extrasgives you access to exclusive benefits, free advice and savings from a range of retailers and providers.
• Stay healthy with Discounted Products - from day one you'll get a 25% discount (on top of other promotions) when you shop at H&B on anything that you buy. 
• We all need a little help sometimes, so we offer Free 24/7 Confidential Advice & Colleague Welfare.
• Mental Health First Aiders- we have lots of qualified Mental Health First Aiders because its all about your health & wellbeing.
• Stay active in the Onsite Gym at our Nuneaton Hub!
• We have colleague Reward and Recognition Schemes, so your hard work and loyalty won't go unnoticed.
• And many more!

#LI-JA1

Holland & Barrett is one of the nation's most loved and trusted brands, known for offering quality health food, vitamins and supplements all sold by highly trained and qualified advisors.

Bucking the current trend of high street retailers, we forecast significant growth and expansion plans in the coming years, with considerable investment going into all areas of the business. We certainly embrace change and drive speed in everything we do. Every day presents a different challenge, but every day is also filled with fun, teamwork and passion to succeed and surpass every expectation.

Join us and see how far you can go…