Regulatory Affairs Specialist
ResponsibilitiesLocation Thane West, MaharashtraIN Job ID JR-019639
PerkinElmer is a global technology company focused on improving the health and safety of people and the environment. The Regulatory Affairs Specialist will support our Diagnostics Business that focuses on products targeted to improve human health. He/she will represent regulatory submissions on global cross-functional teams providing guidance on EU CE-IVD regulatory requirements, review data for sufficiency and lead registration related negotiations.
- Support preparation and timely completion of EU CE-IVD Marking registrations for in vitro diagnostic devices (assays, instruments, software) to meet project and business needs
- Participation on cross functional project teams to provide strategic and tactical guidance to meet IVDD/IVDR & Brexit requirements,
- Support development of regulatory strategy for EU CE-IVD registrations submission and/or global regulatory plans for EU manufactured IVD products
- Assessment and applicable documentation of changes in product, manufacturing processes, labeling affecting IVD products distributed in the EU, including communication to global Regulatory and project teams for impact assessment
- Support global Regulatory teams and/or in-country dealers/representatives with regulatory registrations of EU manufactured IVD products
- Maintain up-to-date knowledge of IVDD/IVDR & Brexit regulations and applicable guidance’s, monitor development of regulations and communicate impact to the business
- Support FDA submission activities for EU manufactured IVD products
- Support day-to-day activities of the Regulatory Product Release system (product classification, set up of licences, release of orders, etc.)
- Bachelor’s degree in life science related field (Medical Technology, Clinical Chemistry, Biology)
- Minimum of 1 years of experience supporting EU CE-IVD Marking registrations for IVD and/or medical devices
- Experience with support for FDA Submissions for IVD and/or medical devices, a plus
- Understanding of IVDD/IVDR & Brexit regulations and guidance documents required
- Understanding of FDA regulations and guidance document, a plus
- Previous experience supporting international registrations
- Limited travel (up to 10-15% of the time, or as circumstances dictate)
- Good interpersonal, verbal and written communication skills (in English)
- Excellent time management, organizational, negotiation, and problem solving skills
- Ability to work independently
PerkinElmer is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. PerkinElmer is committed to a culturally diverse workforce.
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