Exempt / Non-Exempt : Non-exemptEducation : Bachelor's degree required, Masters degree preferredExperience : Minimum of years experienceSkills : Knowledge of US and / or Canadian regulation relating to product and / or device clearance (FDA)Duties : Assists in definition / implementation of regulatory strategy and priorities in conjunction with management, peers, commercial, and affiliate personnel.
Communicates issues to management through project management tracking and issue briefings. Position is highly visible to internal and external stakeholders.
High level of effective verbal and written communication skills must be demonstrated, including ability to negotiate, influence, and manage conflict.
Prior regulatory experience in the medical device, food, dietary supplement or pharmaceutical industry is strongly preferred, but not required.
Ability to work constructively, decisively, and collegiality with internal customers (scientists, marketing, quality assurance, product development, affiliates) to solve problems and communicate regulatory needs.
Ability to manage and track broad and strategic projects. Ability to communicate effectively in writing crisp briefings and issue analysis.
Demonstrated ability to work effectively in a team environment. Responsible for tracking and timely completion of regulatory strategies and issues, scientific substantiation for product claims, and label / promotional material activities.
Responsible for effective communication of regulatory requirements to project teams and internal customers.Equivalent to Grade at Client .
The candidate will assist in various regulatory duties including completion of deliverables and preparation of regulatory submissions for the next-gen clip system.
The position requires that they develop an understanding of the Clip products and manufacturing processes in order to review and assess proposed product changes within the change management system (in Change Orders and Change Requests).
Specific responsibilities will include :
- RA Lead / Core Team Support for manufacturing related submissions
- RA Lead / Core Team regulatory support for international submissions and renewals
- Provide regulatory support for change management activities, including RA impact assessments in Change Requests, Submissions, and approval of change orders to implement approved changes.
- Review and approval of product release process and addendum labeling
- RA project team member for new quality system process changes and updates
EEO :
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