Senior Regulatory Affairs Specialist
CooperSurgical
Fjernarbejde
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. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values – dedicated, innovative, friendly, partners, and do the right thing – our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women’s and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at www.coopersurgical.com.
Responsibilities
At CooperSurgical we are currently looking to recruit a Senior Regulatory Affairs Specialist. You will be part of the global regulatory team with 20 international colleagues. The position is remote but based out of UK. The Sr. RA specialist will be reporting to the RA manager also working out of UK.
Position
In the role of Sr. RA specialist, you will be responsible for regulatory activities such as registration documentation and product applications and renewals to local authorities primarily focus on FDA 510(K) and UK/EU MDR. You will identify and maintain documentation including updates and review of the technical files for the IVF devices product portfolio and support the MDR filling (class I,IIa). You will maintain the regulatory QP/QI´s in the quality management system in corporation with your fellow peers in regulatory affairs.
As a person you thrive in a dynamic and sometimes hectic environment and by using your planning and prioritizing skills, you meet deadlines and proactively follow-up on stakeholders. You will work closely together with teammates, interacting with different internal and external stakeholders. Therefore, it's vital that you possess good communication skills, and are committed to getting things done both individually and together with the RA team.
Your Key Responsibilities
- Lead and support Regulatory projects.
- Medical device submissions to US and UK/EU
- Drive renewals and product applications with local Authority
- Support MDR filling in EU.
- Conduct Regulatory impact assessments.
- Master’s degree in pharmaceutical, chemistry or biology or similar
- + 4 years of experience from Regulatory affairs -preferable from medical device
- Structured and systematic approach
- Prior experience with FDA 510(k) and EU MDR 2017/745
- Project management flair and problem-solving skills
- Proficient level in MS office
- Eye for detail
- Fluent English (spoken and written) is mandatory
- A can-do attitude, positive mindset and empathic
- Team player