Job Reference: J5631425
Updated On: 02/05/2019
Status: Open to Applications
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Role OverviewWe are currently looking for a Head of Regulatory & Compliance to join a leading Medical Device company based north of Cambridgeshire. As the Head of Regulatory & Compliance you will be responsible for developing the Regulatory Strategy for their Medical Device products and will support the design, development and commercialisation of their bespoke combination products.
This is a Leadership position where you will influence company strategy and direction. You will need to apply effective judgement and decision-making in complex business critical situations and be able to work in a face paced environment ensuring a positive working culture for your line reports.
Key Duties and ResponsibilitiesYour duties as the Head of Regulatory & Compliance will be varied however the key duties and responsibilities are as follows:
1. Work with the Director of Quality and Regulatory Affairs to align on the regulatory strategy for all products and provide critical review and input on device design and portfolio regulatory strategies and risk planning.
2. You will sit on the company's Senior Management team and interact with internal key stakeholders to drive company strategy. In addition to the you will have a team of Regulatory Professionals and will line manage staff from associate to manager level.
3. Provide technical guidance to cross-functional teams and ensure EU and FDA regulations are maintained.
4. Ensure submission excellence framework is consistent applied across projects and programmes, including knowledge sharing and leveraging appropriate tools.
5. Lead and host all internal and external Regulatory Audits and investigations to ensure conformity to regulatory and company compliance.
Role RequirementsTo be successful in your application to this exciting opportunity as the Head of Regulatory & Compliance we are looking to identify the following on your profile and past history:
1. Relevant degree in a Life Science discipline in addition to extensive Regulatory Affairs experience within a Medical Device environment where you are experienced with the new MDR.
2. Proven industry experience in a strategic leadership position with an in depth understanding of device
development processes and strategies.
3. Experience in EU & USA Regulatory Filing processes for Medicines and Medical Devices through product life-cycle including injectables, nasal and oral pMDI combination products.
Key Words: Head of | Director | Leader | Leadership | Regulatory Affairs | Compliance | Medical Device | FDA | MHRA |
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