Regulatory Affairs Manager

CooperSurgical Fertility Solutions is the global leader in IVF and reproductive genetics, providing innovative products, services and training for every step in the ART journey.

Healthy women, babies, and families™

At CooperSurgical (CSI) we are currently looking to recruit a Regulatory Affairs Manager for our Technical Specialist RA team. You will be responsible for three direct report and establish the RA strategy for new product delivery and submission within US, UK and EU. You will be part of the UK Regulatory team of 9 employees and report to the Director of Regulatory, based in UK.

The production site is in Falmouth, Cornwall UK and you should be willing to travel to the site once a month.

The position is UK based, requires 10-15% Global and local travelling.

Applicants must be eligible to work in UK and travel without Visa in EU.

Position

In the role as RA Manager for CSI technical RA Specialist team you will be responsible for all regulatory aspects and activities regarding attaining and maintaining EU, US and UK device certifications and market clearance, incl. self-certification of non-medical device (General laboratory equipment). Also the regulatory impact assessment of changes to devices, process, supply chain and regulations, and resultant notification to agencies, will be important responsibility areas. As CSI is developing several new products, cross functional projects have been allocated to the UK RA team and this role. It’s therefore important to have solid project management skills, strong communication and collaboration skills, as this role and RA in general is the interface of several crucial product projects for CSI.

You have strong experience with the regulatory requirements for Class IIa and IIb medical devices especially, technical Documentation Files, Device History Files and RA planning & assessments. Having worked with single use sterile devices, active equipment and software, is a plus for this role.

You thrive in a dynamic and sometimes hectic environment. By using your people management, planning and prioritization skills, you can meet deadlines and follow-up with stakeholders. You will work closely together with teammates and stakeholders in the organization. The position as RA Manager is vital for the success and growth of the CooperSurgical company.

Your key responsibilities

• Lead and manage RA- technical specialist team
• Drive RA projects for new product introduction and legacy products
• Manage technical product files on 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 in relevant Engineer, Bio Science, Technical or alike
• + 3-5 years of experience from a similar role,- preferable medical device production
• 2-4 years managerial experience from an international company
• Global experience in RA with EU, US and UK regulation
• Strong project management- skills
• Structured and systematic approach
• Strong communication and problem-solving skills
• Proficient level in MS office
• Fluent English (spoken and written) is mandatory

Why join CooperSurgical?

We can offer a challenging position within a dynamic, globally leading, high growth company. You will work together with competent colleagues in a positive environment, that welcomes people of all views and backgrounds and provides countless ways to grow and develop.

Interested?

Apply here.

To ensure we continue improving the quality of treatments for women and families, we offer roles that challenge individuals, helping them grow. To make this happen we provide high-quality training, and through collaborative project work and peer support, we believe our work environment helps to nurture talent enabling everyone to excel.