Regulatory Affairs Manager

Coopersurgical are currently looking for a Regulatory Affairs Manager to lead a small team of RA specialists who manage CSI’s expanding portfolio of fertility equipment and consumables. This new position is vital for the success and growth CooperSurgical’s fertility sector and for the right candidate, provides an exciting opportunity to be part of the NPI cross functional core teams currently at the cutting edge of medical device new product development advising strategy to meet the regulatory requirements for global market access.

The role is based in the UK, reporting to the UK Director of Regulatory Affairs and you will be required to travel to the Falmouth manufacturing facility, one of many CSI sites, at least 3-4 times a year. Applicants must be eligible to work in the UK and travel without a Visa in the EU.

It is essential that you have experience in managing complex regulatory projects for the timely introduction of new products to market as well as the knowledge required to maintain international market access for existing devices subject to change. Your core responsibilities will be to manage all the regulatory aspects of fertility medical devices and self-certified non-medical general lab equipment sold to the EU, US and UK. As such you will have extensive knowledge of the regulatory requirements for Class I, IIa and IIb single use sterile devices, active equipment and software as medical devices, including EU MDR technical file review and US 510K, PMA submission experience. Regulatory impact assessments of changes to devices, process, supply chain and regulations, will also be a focus area.

You thrive in a dynamic and collaborative environment, where you can use your people management, planning and prioritization skills to meet project deadlines and deliverables. You will have proven managerial experience, with excellent communication and collaboration skills. You will be responsible for supporting all aspects of your teams workload, their professional development and interaction with the wider Cooper family.

Your Key Responsibilities

• Lead and manage a small team of regulatory specialist professionals

• Drive RA projects to deliver new products and maintain legacy products

• Generate and maintain regulatory documentation all level of CSI products

• Ensure KPI and timelines are meet

• RA advisor and representative for NPI from concept to delivery

• Foster team spirit and global collaboration

Your Qualifications

• MSc degree in relevant discipline Engineering, Biosciences, Technical or similar

• + 4 years of experience in a similar role within medical device industry

• 3-5 years managerial experience with an international company

• Extensive regulatory knowledge of requirements in EU, US and UK for medical devices

• Effective project management, prioritization and organisational skills

• Efficient structured and systematic and hands-on approach to completing tasks

• Strong communication with collaborative, supportive style

• Proficient level in MS office

• Fluent English (spoken and written) is mandatory