As the Manager, Regulatory Affairs, you will be responsible for contributing towards development and implementation of regulatory policies and registration strategies for systems and informatics products that serve the global research and regulated markets. You may be assigned new/additional role(s) based on business requirements. You will develop and drive a work culture committed to compliance, quality and customer focus.
Manages regulatory responsibilities associated with the development, support, and manufacturing of the Company’s medical device products (including compliance).
Manages the development and implementation of Regulatory strategies and plans to support the timely introduction of new products and the preparation and review of government submissions to achieve timely and cost effective clearance/approval. Provides information for maintaining registrations and listings.
Monitors and assesses Regulatory developments (e.g. Federal Register publication/notices, FDA guidelines) related to the Company’s products.
Reviews product labeling to ensure conformance with Regulatory requirements and/or approved product claims.
May serve as a contact with affiliates to achieve international registration of devices.
Frequent contact with external resources and contacts at various management levels concerning operations or scheduling of specific phases of projects.
Position may have HR responsibility for direct and indirect reports which includes hiring/firing decisions, interviewing, selection, performance feedback, discipline, pay decisions and handling employee grievances/complaints.
Oversees the “agent in charge” for audits and serves as primary liaison with plant compliance officers to direct strategy and documentation requests during an audit.
Manages staff; provides staff with coaching, training and opportunities to develop skills, and gives ongoing, constructive and timely feedback on performance and progress toward goals and expectations.
Other duties as assigned by management.
Bachelor's degree in Chemistry, Biology, Biochemistry, or other related field
5 years experience working in an FDA-regulated industry
10%, based on business needs.