Sr. Regulatory Affairs Specialist
Michigan, Kalamazoo-Battle Creek
Our client, a Global Medical Device Manufacture has an immediate opening for a Sr. Regulatory Affairs Specialist 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.
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
Bachelor s Degree: Liberal Arts, Science, Engineering or related field required.
MS and/or RAC preferred.
2-3 years related experience
Experience in a regulated industry and change control is a MUST HAVE
Developed and applied basic knowledge and understanding of the regulatory and legal framework, regulatory requirements, legislation, processes, and procedures.
Must thrive in a team environment, build strong relationships and demonstrate leadership capabilities.
Must have excellent interpersonal communication skills specially relating to people, conflict, and stress management.
Must have a passion for continuous improvement and demonstrated problem solving skills.
Must have a passion for quality and procedural compliance.
Must have excellent time management skills with the ability to use judgment effectively.
Competent with Microsoft Office (Outlook, Excel, Word, etc.).