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 Regulatory Affairs Specialist for an 18-month contract to cover maternity leave. You will be part of the global regulatory team, but primarily work with the UK RA based team. For this position you can be based in UK or EMEA and have an opportunity to work from home, remotely. This role will be reporting to the RA Manager based in UK.
Position
In the role of RA Specialist, you will be responsible for submissions globally but primarily focusing on MEA and LATAM. You have strong experience with global product registration and re-registration and adept at liaising with the right people to collect and gather the relevant documentation and files. You will be responsible for completing annual renewals and following up on deadlines and tasks, to meet submission timelines. Preferable you have worked with single use sterilized products and electrical, electronic devices, and be familiar with the appropriate standards and regulations.
As a person you thrive in a dynamic and busy environment which provides you with an opportunity to use your planning and prioritization skills to meet deadlines and progress registration projects. You will work closely together with other RA professionals and cross functional stakeholders in this international organization.
The position as RA Specialist is vital for the success and growth of CooperSurgical.
Your key responsibilities
* Lead regulatory activities, reviewing, maintaining, and submitting files and legalized documentation
* Facilitate collection of data for international registrations
* Complete administrative RA tasks
* Monitor for any change in META & LATAM medical device regulations
* Liaise with stakeholders globally
Qualifications
* MSc in relevant field Engineer, Bio Science, Technical or alike
* + 2-3 years of experience from a similar role -preferable
* Global submission experience
* Structured and systematic work ethic
* Strong communication and problem-solving skills
* Proficient level in MS office
* Fluent English (spoken and written) is mandatory
* A can-do attitude and proactive approach
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