About this role
About 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. 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.
Short Description
Lead RA activities in Russia, EAEU, other Russian speaking countries, and manage RA activities in allocated markets in Middle-East and Africa, by collaborating with internal and external relevant stakeholders to ensure regulatory requirements are processed timely and efficiently to ensure compliance with markets regulations and ensure successful business continuity.
Description
- Ensure compliance with local regulatory requirements in Russia, EAEU, other Russian speaking countries and in allocated markets in Middle-East and Africa, for medical devices marketed or intended to be marketed.
- Support with the submissions management including new registrations and registrations maintenance, with relevant channel partners and health authorities across the region.
- Responsible for conducting change notification and regulatory assessments.
- Monitor proactively regulatory developments and changes in legislation in assigned countries, assess potential impact and advising internal relevant stakeholders.
- Work closely with relevant internal departments to ensure regulatory requirements for assigned countries are integrated into necessary projects or commercialization process.
- Maintain comprehensive and accurate records for all regulatory activities and submissions, ensuring documentation meets requirements of company standards.
- Collaborate with global Regulatory Affairs teams as needed to ensure alignment of activities and sharing best practices.
Other facts
About CooperCompanies
CooperSurgical is driven to advance the care of women, babies, and families around the world. We believe in empowering individuals and healthcare professionals in making health and life choices. We are trusted by clinicians worldwide for products, technologies, and services that support a wide range of reproductive solutions, from contraception to fertility and preventative and therapeutic gynecological care.
What you'll do
- Lead regulatory affairs activities in specified regions, ensuring compliance with local regulations for medical devices. Collaborate with internal and external stakeholders to manage submissions and monitor regulatory developments.
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