Role: Head of Regulatory - Medical Devices - Non-licensed - FTC 12 - 18months
Location: Hull
Salary: Highly Competitive
Science Solutions Recruitment has a fantastic opportunity for a Head of Regulatory for a world leading Medical Device Company based in Hull. This is a 12 - 18 months FTC and my client are looking for someone with a background in Medical Devices non-licensed products. This is a critical function to work with key stakeholders in developing the right portfolio for innovation and activation in the medical device markets.
Role:
- Strategic leadership of global consumer product development and registration projects for Global Footcare category to meet the business objectives.
- Manage a complex and diverse set of registration/regulatory requirements across multiple markets to enable strategic global pipeline delivery.
- Ability to translate complex regulatory information into a compelling stakeholder friendly language.
- Work collaboratively with team in order to define and implement the regulatory strategy & global registration dossiers.
- Review and approval of European Medical Device Technical Files and Declarations of Conformity.
- Provide regulatory strategy assessments of internal and external commercial opportunities in concert with appropriate technical and regional/local regulatory input.
- Working with country regulatory, support and where necessary lead Health Authority meetings/negotiations in support of submission and approval of strategic new product registrations in critical markets.
- Work in partnership with the local regulatory teams (or agencies) to identify and be aware of key requirements and that they are taken into account to deliver a 'right first time' approach to new product development.
- Influence externally where appropriate industry led regulatory reviews and initiatives of direct relevance.
- Take the regulatory lead in the preparation of responses to address significant safety, regulatory and PR issues in the assigned Category, including support internal investigations into allegations of non-compliance.
- Devise, and deliver to business partners, training materials that optimally prepare the business for the present and future regulatory environment.
- Ensure through dynamic resourcing that appropriate support is given to the Innovation projects & team.
- Supports work required to refine Regulatory processes and procedures to optimise accuracy and efficiency, thus enabling speed to market.
- Provide oversight and accountability for setting up and delivery of Product Safety of our products with aid of external agencies
- Support in audits, including those conducted by various Health Authorities & Notified Bodies
- People management including direct line management & development to build an efficient team
Person:
- Educated to honours degree level in a scientific field or equivalent experience
- Extensive Regulatory Experience (10+ years) and knowledge in NPD and dossier/technical file creation / maintenance and global registrations.
- Extensive experience in medical device and cosmetic registration across Europe, Australia/New Zealand and good understanding of ROW registration and strategy.
- Good knowledge of different regulatory classifications including medicines, cosmetics, general products & Biocides
- Experience in preparing and submitting dossiers, variations and renewals.
- Understanding of global product development practice, rules, regulations and guidelines.
- Familiarity with factors likely to influence the regulatory environment, including new and emerging guidelines relevant to dossier deliveries.
- Ability to consistently deliver to time, cost and quality standards in a high-pressure environment
- Strong people development and line management experience
