Manager, Regulatory Affairs

at  CooperSurgical

CooperSurgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. CooperSurgical is at the forefront of delivering innovative assisted reproductive technology and genomic solutions that enhance the work of ART professionals to the benefit of families. We currently offer over 600 clinically relevant medical devices to women’s healthcare providers, including testing and treatment options.
CooperSurgical is a wholly-owned subsidiary of CooperCompanies (Nasdaq: COO). CooperSurgical, headquartered in Trumbull, CT, produces and markets a wide array of products and services for use by women’s health care clinicians. More information can be found at www.coopersurgical.com .
MSc in relevant field 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
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.

• 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