Sr. Regulatory Science Specialist

Michigan, Kalamazoo-Battle Creek

Posted: 05/07/2019 Industry: Other (HR, Admin, Mkt, Sales) Job Number: 13042

Our client, a Global Leader in the Medical Device Industry has an immediate opening for a Facilities Management Coordinator for a 12 month + Contract. Our client offers results-driven people a place where they can make a difference every day! You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment.

Position Description (Principle Duties and Responsibilities)

Provides subject matter expertise in the requested technology or application. Assists client in implementing, upgrading or optimizing specific technology. Utilizes professional expertise to perform analysis, project management and/or development activities with technology. Requires demonstrated subject matter expertise in the specified technical area.

Experience in a regulated industry and change control is a MUST HAVE!
Evaluate regulatory impact of proposed changes to Launched Products
Demonstrate understanding and ability to investigate and evaluate regulatory history/background of class, disease/therapeutic/diagnostic context in the assessment of regulatory implications
Ensuring Compliance with Product post-approval or clearance requirements.
Approving labelling, advertising, and promotional items for compliance before release.
Reviewing publicly disseminated information to minimize regulatory exposure
Reviewing product claims and preserving confidentiality of applicable product information
Reviewing change management to determine the level of change and potential submission requirements
Evaluating proposed pre-clinical, clinical, and manufacturing changes for regulatory filing strategies

Qualifications:

Bachelor s Degree in Regulatory or related Engineering field required
Change Control background is required
Understanding and ability to investigate and evaluate regulatory history/background of class, disease/therapeutic/diagnostic context in the assessment of regulatory implications
Utilizing professional expertise to perform analysis, project management and/or development activities with technology

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