Principal Regulatory Specialist UK, Ireland, Malta and Nordics - #1692178

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

Your role at Vantive

As the Principal Regulatory Specialist, you will be responsible and accountable for all local operational aspects of regulatory submissions providing planning and technical support for Vantive products in UK, Ireland, Malta and Nordics countries.

Instrumental in the design and definition of the Regulatory strategy for the products, you’ll be part of the CQA/RA team and support local CQA activities as needed.

This is a fully remote role based in the UK including occasional travel within UK, Ireland and Nordic countries.

What You’ll Be Doing

• Develop and execute regulatory plans aligned with business strategy for complex projects including new products and maintenance of licenses/ authorizations for existing products.
• Identify & prioritize key areas of risk and develop & implement appropriate mitigation plans.
• Monitor applicable regulatory requirements and support global Regulatory Intelligence process; assure compliance with Vantive and external standards.
• Perform gap analysis on regulatory documentation and propose solutions, as well as identify areas for improvement.
• Provide local support for Medical Device registrations including maintaining local device databases, by developing and documenting sound regulatory decisions and justification.
• Establish appropriate communication within RA, with local Marketing, and with other functions primarily at project level and favor proactive communication.
• Ensure regulatory strategy and deliverables are aligned with project teams and business objectives.
• Lead regulatory activities for UKIEMT and Nordics. Be the point of contact for regulatory authorities on behalf of the Company.
• Prepare, review, and approve labeling, SOPs and AdProm materials for compliance with local regulations and Vantive procedures.
• Represent or lead the RA function on assigned cross-functional project teams.
• Represent Vantive interests in industry and working groups.Maintain/coordinate local Regulatory contracts.
• Train new employees of the cluster to RA. Be the contact for other functions and departments (Customer Service, Medical affairs, Technical Service, Pharmacovigilance, tenders, etc.) for RA – related questions.
• Lead on local activities for the implementation of UK Regulations for Medical Devices.
• Interpret existing, pending and proposed regulations/guidance documents for the CE marking, UK Regulations – providing assessment on impact to Vantive.
  
  

What You’ll Bring

• Bachelor’s degree or country equivalent in a scientific discipline, Masters and/or PhD will be an advantage.
• Extensive regulatory experience in RA, specifically learning RA work streams within regional and/or global projects drawing on expert regulatory knowledge covering both drugs and devices
• Proven experience in conducting risk/gap analysis in a regulatory environment, and implementing action plans
• Confirmed experience in liaising with external bodies (e.g. MoH, Notified Bodies, Industry Bodies) as well as training others within RA.
• Strong organizational skills
• Excellent communicator at all levels within an organization
• Strong stakeholder management skills
• Excellent attention to detail
  
  

Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link

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