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 RESPONSIBILITIES:
Your 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.
To 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 |
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.