Description
Center Valley, PA - The Associate Manager, Regulatory Affairs will be responsible for the regulatory program for product introduction, ensuring that all Scientific Equipment Group (SEG) products are compliant with Food and Drug Administration laws and regulations for medical device clinical evaluation, regulatory clearance, and distribution. The incumbent will also maintain the overall compliance program for medical device labeling for the SEG Group. EOE M/F/D/V
* Interact with Manufacturing Business Centers (M-BCs) to ensure smooth and timely product introductions complying with all existing FDA regulations, such as 510(k) and IDE. Assist M-BC in the preparation and submission of premarket notifications [510(k)] for domestic distribution of medical devices. Counsel M-BCs regarding regulatory requirements for FDA medical device clearance. Coordinate, prepare, and submit medical device applications for regulatory clearance with the Health Protection Branch, Canada.
* Interface with vendors regarding regulatory issues related to product design, performance, manufacturing, labeling, and quality issues.
* Manage the clinical trial program for product evaluations conducted in the U.S. prior to product regulatory approval. Establish, implement, maintain, and enforce policies and procedures relative to user device evaluation that are compliant with existing FDA regulations for clinical trials and assessment.
* Manage the labeling policy for all SEG products. Ensure regulatory accuracy for all device labeling and interact with M-BCs for labeling review issues to ensure the smooth and timely review of product labeling.
* Serve as the department’s liaison with the Marketing department for new product introductions.
* Perform other related duties as assigned.
Requirements
(ONLY QUALIFIED CANDIDATES WILL BE CONSIDERED)
* A 4-year degree in a technical discipline such as Electrical Engineering, Mechanical Engineering, Industrial Engineering, Chemistry, Biology, etc., or equivalent knowledge, with a minimum of 4 years in Regulatory Affairs/Quality Assurance in medical devices (preferably) or a pharmaceuticals related field is required.
* A demonstrated leadership ability, as well as the ability to effect change within an organization, are highly desirable.
* Strong analytical, organizational, communication, and interpersonal skills are essential.
