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Regulatory Affairs Specialist Jobs in Mumbai - PerkinElmer

CW
Regulatory Affairs Specialist
PerkinElmer
Other Course, BSc
1 Years
PerkinElmer
Last Date 07 Aug 2020
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PerkinElmer - Job Details

Date of posting: 07 Jun 20
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 US regulatory requirements, review data for sufficiency and lead registration related negotiations.
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.)
Qualifications
  • 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 : Full Time
Job Role : Others
Job Category : BSc/BCA/BBM
Hiring Process : Face to Face Interview
Who can apply : Experienced (1 Years)

About PerkinElmer

PerkinElmer
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PerkinElmer recruiting Regulatory Affairs Specialist Experienced(1 Years) 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 Years) candidates candidates every year based on the skills . The candidates with Other Course, BSc are selected to full fill the vacancies in Others 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 Others . 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.