Kelly Hiring for Regulatory Affairs Specialist at Rochester, New York Metropolitan Area Full Time

Kelly Services has an opportunity for a Senior Regulatory Affairs Specialist for a major medical supply manufacturer in Rochester!

This is a contract role that would likely run 3 to 4 years. Hours are typical office hours (EST) with some flexibility. Position comes with full benefits including 3 weeks of PTO, 8 paid holidays, 401K, and medical/dental/vision insurance options.

Type: Full Time Consultant

Responsible for providing Regulatory Affairs support to gain or maintain regulatory authorizations to market medical devices in the US, EU and/or Project Lead Markets. This position requires the incumbent to prepare submissions, review and approve product labeling & advertising, support facility inspections and participate in other regulatory support activities as required. Primarily focused on US / EU and support of lead market Regulatory Affairs activities. This position interfaces with internal functions and may also have contact with government agencies I regulatory authorities.

Key Responsibilities:

• With the oversight of Regulatory leadership, develops regulatory strategies and timelines for product development and product improvement projects. Generates submissions (i.e. PMA, 510(k), PMA supplements, CE Mark submissions) to obtain various approvals to commercially distribute products. This requires participation in product development teams, as well as responsibility to review, analyze, and comment on technical reports. This also may require interaction with government officials on product submissions and approvals.
• Produce subsequent submissions (annual reports, change notifications, etc.) to facilitate the maintenance of product approvals.
• Support creation, update, review and approval of labeling content for B+L device products.
• Review and provide input on departmental policies and procedures.
• Provide input and comment to regulations standards which may affect B+L products.
• Other job responsibilities as needed.

Requirements:

• BA/BS degree in a technical or scientific discipline. Additional professional training a plus.
• Must possess at least an advanced level of performance in the majority of the following core competencies: influence key stake holders, business acumen, project management, relationship building, regulatory expertise.
• 3-5 years in a Regulatory environment with demonstrated success