Regulatory Affairs Manager - Kelly Scientific Resources

Location: Saint Louis Park, MN
Categories: Scientist
Website: http://www.kellyscientific.com

Position Description

Summary:
Direct Regulatory submission activities to FDA and International markets. Prepare regulatory strategies/plans and worldwide requirement lists, including prioritization of submissions and other associated activities. Negotiate directly with FDA on projects/products. Participate on process/product improvement teams and provide leadership to product development teams for regulatory issues and questions. Provide regulatory support for market-released products as necessary. Provide leadership, management, work direction, training, and project advice to members of the Regulatory staff. Ensure the support of Regulatory Affairs staff for submission activities. Assist staff with setting of objectives, professional development, and process improvement initiatives. Make personnel decisions to ensure harmony with overall department goals. Establish and maintain department budget.

Specific duties include:
• Manage Regulatory personnel in such areas as objectives, projects and responsibilities.
• Assess regulatory requirements and develop worldwide regulatory strategies to obtain timely regulatory approvals.
• Prepare US and international submissions for new products and for products with significant changes.
• Develop proficiency in worldwide regulatory requirements, establish, and maintain good working relationships with regulatory agency personnel.
• Provide support to market-released products by reviewing change orders, labeling, promotional materials, documentation of changes, and maintaining product files to ensure compliance with regulatory requirements.

Requirements:
4-year Bachelor’s degree, with preference of biological science, health or related field. At least 5 years of related experience in the medical device industry, 3-5 yrs experience in regulatory and 2 years of supervisory experience. Strong knowledge of both domestic and international device laws and regulations is required. Must have demonstrated proficiency with regulatory planning and strategy as well as submission planning and preparation. Good personal computing skills and Internet Applications. Demonstrated excellence in professional written and verbal communication skills is essential. High level of research, analytical problem solving, and project management skills are required, as well as a strong attention to detail. Must have the ability to work closely with other personnel/departments in providing strong internal regulatory services. Ability to plan and prioritize effectively, handle multiple projects, and work independently in meeting deadlines is a must. Intermittent standing and sitting is involved, as well as repetitive motion tasks such as those associated with word processing. Periodic lifting (less than 30 pounds), and occasional overnight travel is involved.

How to Apply

Please email your resume to leiernl@kellyservices.com

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