Regulatory Affairs Specialist Jobs in Mumbai - PerkinElmer

Regulatory Affairs Specialist
Last Date 06 Feb 2021
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PerkinElmer - Job Details

Date of posting: 06 Dec 20
Key Responsibilities
Support preparation and timely completion of FDA submissions for in vitro diagnostic devices (assays, instruments, software) to meet project and business needs (Pre-Submission, 510(k),de Novo, PMA supplement, PMA annual report, etc.)
Participation on cross functional project teams to provide strategic and tactical guidance to meet US FDA requirements,
Support development of regulatory strategy for US submission and/or global regulatory plans for US manufactured IVD products
Assessment and applicable documentation of changes in product, manufacturing processes, labeling affecting IVD products distributed in the US, 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 US manufactured IVD products
Maintain up-to-date knowledge of US IVD regulations and applicable guidance’s, monitor development of regulations and communicate impact to the business
Support CE marking activities for US 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 FDA submissions for IVD and/or medical devices
Understanding of FDA regulations and guidance documents required
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

Job Summary

Job Type : 0
Job Role : HR / Admin
Job Category : BSc/BCA/BBM,Recruitment
Hiring Process : Face to Face Interview
Who can apply : Experienced (1 yrs)

About PerkinElmer

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PerkinElmer recruiting Regulatory Affairs Specialist Experienced(1 yrs) candidates candidates nearby Mumbai.PerkinElmer vacancies for Regulatory Affairs Specialist is recruited through Written-test, Face to Face Interview etc.
PerkinElmer Company recruits a lot of Experienced(1 yrs) candidates candidates every year based on the skills . The candidates with ME/M.Tech, M.Com, BBA/BBM, BSc, BCA, MBA/PGDM, BE/B.Tech, MS, 12th Pass (HSE), PG Diploma, MSc, Diploma, B.Com, MCA are selected to full fill the vacancies in HR / Admin job field. The candidates nearby Mumbai can apply for Regulatory Affairs Specialist position in PerkinElmer. All candidates should have a degree or post-graduation in the required field based on the requirement mentioned. The jobs are available in Full Time basis. When it comes to the PerkinElmer recruitment, candidates are mostly chosen for the department of HR / Admin . To learn more about the current jobs and other details, it is better to go through official site of PerkinElmer and Freshersworld. Find the latest jobs near you and near your home. So, that you don’t need to relocate. The Freshersworld is a leading employment portal that researches the official site of PerkinElmer and provides all the details about the current vacancies, the application process, selection process, interview test details, important dates and other information. Search and apply for the top job positions in PerkinElmer and near your city and get a secured career.