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 atwww.coopersurgical.com.
Responsibilities
At CooperSurgical (CSI) we are currently looking to recruit aRegulatory 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 asRA Managerfor CSI technical RA Specialist team you will be responsible forall regulatory aspects and activities regardingattaining 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. Its 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 experiencewith 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.
Responsibilities
Qualifications
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
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