Job title: Regulatory Affairs Associate
Company: PerkinElmer
Job description: Job Title Regulatory Affairs Associate
Location(s) India – Remote
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 support regulatory submissions on global cross-functional teams and help to providing guidance on regulatory requirements.
Key Responsibilities:
- Supports international registration of new products which may include US, Canada, and EU.
- Supports post-approval reports, annual reports, export certificates, and establishment registrations and device listings.
- Supports global Regulatory teams and/or in-country dealers/representatives with regulatory registrations of US-manufactured devices
- Develops and maintains knowledge of US IVD, Health Canada and EU regulations and applicable guidances
Qualifications:
- Bachelors Degree in life science related field
- Minimum of 3 years experience in a Quality, Regulatory or Clinical role
- Previous regulatory/quality experience supporting international registrations a plus
- Limited travel (up to 10-15% of the time, or as circumstances dictate)
- Excellent interpersonal, verbal and written communication skills (in English)
- Excellent time management, organizational, negotiation, and problem-solving skills
- Ability to work independently and in a matrixed organizational structure, developing strong relationships with peers and levels of management
Expected salary:
Location: India
Job date: Fri, 22 Jul 2022 05:11:50 GMT
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