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Show Printable JobRegulatory Affairs Manager / Sr Reg Specialist - IVD
As seen in BostonJobs.com
id="tms_job_264-001-2010">Regulatory Affairs Manager / Sr Reg Specialist - IVD
Job Type :Full Time
Career Level :Experienced (Non-Manager)
Education :Bachelor's Degree
Job Description :
PerkinElmer is a global technology company focused on improving the health and safety of people and the environment. The Regulatory Affairs Manager will support our Genetic Screening Business support In Vitro Diagnostic (IVD) products targeted to improve prenatal, neonatal and child health. He/she will represent regulatory submissions on global cross-functional teams providing guidance on US regulatory requirements, review data for sufficiency and lead FDA submission related negotiations.
Key Responsibilities:
Preparation, filing and maintenance of US regulatory submissions, including 510ks, 513gs, PMAs, preIDEs, and IDEs for new and modified products
Understand and interpret US in vitro diagnostic device regulatory requirements and provide guidance on requirements to product development teams
Partner closely with R&D and clinical evaluation teams based in Finland and the US to guide regulatory process
· Provide input into the design of clinical trials to fulfill regulatory requirements
Act as interface with US regulatory agencies (FDA, CMS)
Assist with the preparation of regulatory presentations and attend meetings with US agencies
Provide review and approval of product labeling and promotional materials
Job Requirements :
Bachelors Degree in the Sciences (Medical Technology, Clinical Chemistry, Biology, Engineering)
Advanced Degree, MS or PhD in related biological and life science field desired
3+ years of industry experience in Regulatory Affairs forin vitro medical devices
Experience writing/submitting FDA submissions (510k and PMA)
RAC certification and experience with CeSub filings preferred
Limited travel (up to 15-20% of the time, or as circumstances dictate)
Excellent communication, organizational and project management skills
Independent and self-directed individual
Successful experience working with cross functional teams across multiple work locations
Benefit overview
Competitive compensation plan / Top notch training and development / Comprehensive benefits package / Paid time off and holidays / Generous tuition reimbursement plan / 401(k) with match and immediate vesting / An environment that fosters career growth.
PerkinElmer is an equal opportunity employer
% of Travel Required :0-10%
Job Type :Full Time
Career Level :Experienced (Non-Manager)
Education :Bachelor's Degree
Job Description :
PerkinElmer is a global technology company focused on improving the health and safety of people and the environment. The Regulatory Affairs Manager will support our Genetic Screening Business support In Vitro Diagnostic (IVD) products targeted to improve prenatal, neonatal and child health. He/she will represent regulatory submissions on global cross-functional teams providing guidance on US regulatory requirements, review data for sufficiency and lead FDA submission related negotiations.
Key Responsibilities:
Preparation, filing and maintenance of US regulatory submissions, including 510ks, 513gs, PMAs, preIDEs, and IDEs for new and modified products
Understand and interpret US in vitro diagnostic device regulatory requirements and provide guidance on requirements to product development teams
Partner closely with R&D and clinical evaluation teams based in Finland and the US to guide regulatory process
· Provide input into the design of clinical trials to fulfill regulatory requirements
Act as interface with US regulatory agencies (FDA, CMS)
Assist with the preparation of regulatory presentations and attend meetings with US agencies
Provide review and approval of product labeling and promotional materials
Job Requirements :
Bachelors Degree in the Sciences (Medical Technology, Clinical Chemistry, Biology, Engineering)
Advanced Degree, MS or PhD in related biological and life science field desired
3+ years of industry experience in Regulatory Affairs forin vitro medical devices
Experience writing/submitting FDA submissions (510k and PMA)
RAC certification and experience with CeSub filings preferred
Limited travel (up to 15-20% of the time, or as circumstances dictate)
Excellent communication, organizational and project management skills
Independent and self-directed individual
Successful experience working with cross functional teams across multiple work locations
Benefit overview
Competitive compensation plan / Top notch training and development / Comprehensive benefits package / Paid time off and holidays / Generous tuition reimbursement plan / 401(k) with match and immediate vesting / An environment that fosters career growth.
PerkinElmer is an equal opportunity employer
% of Travel Required :0-10%
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