Regulatory Affairs Manager

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Job description

Responsibilities:

Assist in various regulatory duties including completion of deliverables and preparation of regulatory submissions for the next-gen clip system.

Develop an understanding of Clip products and manufacturing processes to review and assess proposed product changes within the change management system.

Provide regulatory support for manufacturing-related submissions and international submissions and renewals.

Support change management activities, including RA impact assessments in Change Requests, Submissions, and approval of change orders.

Review and approve product release process and addendum labeling.

Act as an RA project team member for new quality system process changes and updates.

Requirements:

Bachelor's degree required, master's degree preferred.

Minimum of 7 years of experience in regulatory affairs.

Prior regulatory experience in the medical device, food, dietary supplement, or pharmaceutical industry preferred.

Knowledge of US and/or Canadian regulations relating to product and/or device clearance (FDA).

Effective verbal and written communication skills, negotiation skills, and conflict management skills.

Ability to work constructively with internal customers to solve problems and communicate regulatory needs.

Ability to manage and track broad and strategic projects.

Demonstrated ability to work effectively in a team environment.

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