Job Description:
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Provide Regulatory Affairs support to manage product development projects to include 510(k), PMA, IDE, label/advertising review and other Regulatory Affairs support activities.
Job Duties:
Prepare US and non-US product submissions such as 510(k), PMA, IDE, CE technical file. This requires participation in product development teams as well as to review, analyze and comment on technical reports.
Review, approve, and provide guidance for labeling and advertising of B&L device products. Counsel technical and business groups to establish direction, based on available data and regulatory considerations.
Provide review and guidance of failure Investigations and corrective actions referred to Regulatory Affairs. Provide guidance on Regulatory compliance.
Review and approve policies and procedures.
Interact with US and non-US government officials on product approval and compliance issues.
Provide input and comment to regulations and standards which may affect B&L device products.
Education: BA/BS degree in a technical or scientific discipline. Advanced degree or additional professional training would be of value.
Experience:
Minimum 5-7 years experience in Regulatory Affairs with a demonstrated capability and experience preparing submissions for US Class II/Class III medical devices, as well as non-US medical device products.
10+ years experience in the medical device or drug industry desired. Knowledge of medical device or drug GMPs desired.
Special Skills:
Must have excellent communication, organization, and writing skills.
Specialized Training: Computer literate with general office software and internet use.
Work Location NY - Rochester-1400 N Goodman Street
Relocation Available Yes
Status Full-Time
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