Senior Regulatory Affairs Specialist (JD)

Founded in 1981, Atrium is a privately held healthcare products company located in Hudson, NH. Atrium is a market leading manufacturer of breakthrough medical device technologies used in open heart surgery, emergency chest trauma, thoracic drainage and surgical repair of diseased blood vessels. More recently, Atrium is known for its high technology presence in coronary stents, minimally invasive intervention of peripheral blood vessels, state-of-the-art hernia repair, drug delivery research, hemodialysis access, and market leadership in facial plastic surgery. Atrium manufactures over 1,000,000 sterile medical products each year which are distributed to over 60 countries. Maintaining a commitment to innovation in research, market development and manufacturing has enabled the company to excel in many global medical device markets. With more than two decades of experience, Atrium has been an innovator of new technologies designed to meet the clinical needs of the patient. Whether it is chest drainage, drug delivery, drug coated stents, or new ways to deal with vascular disease and general surgery, Atrium is working on a new and innovative ways to solve unmet clinical needs. Atrium offers a unique opportunity with exciting challenges for the qualified candidate.

Overview

Responsible for Internal, Domestic and International compliance activities.

Position Specific Requirements

 Prepares Regulatory strategy/plans and requirements. Prepares worldwide regulatory submissions/registrations and obtains approval. Participates in the review and disposition of labeling, promotional material and product modifications. Prepares documentation and coordinates activities related to PMA's, 510k's and IDE's. Supports engineering changes through RA/QA practices by documenting the changes in compliance with the Quality System Regulations, the Medical Device Directives, CMDR and other International regulations. Participates in meeting departmental goals such as modifications to existing quality system related policies and procedures. Participates in cross-functional departmental team projects and product development activities/meetings. Provides interface between regulatory agencies such as the Food and Drug Administration (FDA) and the European Notified Body. Responsible for FDA/ISO/MDD/CMDR compliance documentation. Performs other related duties as required. 

Qualifications 

 

Bachelors Degree in related field and a minimum of five years of directly related experience in Regulatory Affairs in a GLP/GMP environment. Knowledge of FDA and International regulatory requirements and systems.  Demonstrated proficiency with regulatory planning and strategy.  Effective communication and interpersonal skills to interact with all levels of inside and outside personnel.  Strong negotiation skills along with effective project management skills.

Atrium Medical Corporation offers competitive salaries, exceptional benefits, and a business casual dress code. We do not accept unsolicited Agency Resumes. Atrium Medical Corporation is an equal opportunity employer dedicated to workforce diversity and a drug and smoke-free environment. Drug screening is required.