Head of Regulatory - Medical Devices - Non-licensed

Job Description

Role: Head of Regulatory - Medical Devices - Non-licensed - FTC 12 - 18monthsLocation: HullSalary: Highly CompetitiveScience 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-licensedproducts. 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

Keyskills :
RegulatoryISO 13485medical devices