Manager, Regulatory Affairs

Datascope is a FORBES BEST 200 SMALL COMPANY.  Datascope Corp. is a market leader in manufacturing proprietary products for clinical health care markets in interventional cardiology and radiology, cardiovascular and vascular surgery, anesthesiology, emergency medicine and critical care, and we continue to bring innovation to this market segment.  The Company’s three primary businesses include Cardiac Assist, Patient Monitoring and Intervascular.  At this time, the Cardiac Assist Division is looking to add a Manager to their Regulatory Assist team in Fairfield, NJ.

 

General Responsibility and Reporting:

To support and be responsible to the Vice President of Quality and Regulatory to assure that the CA Division

Complies with the laws and medical device regulations for the countries in which the Division conducts business.

 

Accountability Objective:

Direct, manage and develop activities necessary for compliance with all U.S. and foreign laws, regulations and guidelines regarding the filing of medical device submissions needed to obtain clinical research and marketing permits.  Act as internal consultant to divisional management in resolving regulatory issues and in developing regulatory strategies for Cardiac Assist Division products.

 

Essential Functions:

Direct and manage all activities associated with world-wide product applications and/or 

registrations in accordance with applicable laws, regulations, and Corporate policies.

Correspond directly with regulatory authorities. Obtain required certificates/approvals

from regulatory bodies to legally release product in the marketplace. 70%

 

Develop regulatory strategies for new products and product modifications. R.A.

representative on project teams. Ensure new product development in accordance with

applicable regulatory requirements. 15%

 

Manage activities of clinical investigations including the development of Investigator’s

Brochure, Investigator’s Plan, Informed Consent form etc. Ensure that all investigations

are approved by regulatory authorities prior to initiation. 10%

 

Provide regulatory review and approval of Engineering Change Requests (ECN’s) and/or 

Sales & Marketing materials/advertising (MLCN’s) and if applicable provide necessary

documentation to support regulatory decisions. 5%

 

Decision-Making Authority:

Provide guidance and make recommendations to clients regarding all regulatory matters.  Final approval by Corporate is sought for all FDA compliance issues and submissions of new products.  Make recommendations regarding departmental budget allocations. Regulatory Affairs approval of ECN’s and MLCN’s.

 

Position Specifications:

1. Knowledge/Educational Requirements

Bachelor’s degree and 3-5 years of related work experience. Additional educational degrees, or extensive work experience in the regulatory or related field may substitute for work experience. Basic knowledge of 510(k), IDE, PMA, and European Medical Device Directive regulatory requirements.

 

2. Skills and Abilities

Strong interpersonal, communication, writing and organizational skills required to effectively work in a regulatory and project team environment.  Strong analytical and mathematical skills are required to interpret and analyze scientific test data for regulatory submissions.  Knowledge and ability to source current regulation information is essential.  Good computer skills (Word processing, spreadsheets, graphics).

 

3. Physical Demands/Work Environment

Normal office environment. May require domestic and some international travel and between local company offices.

 

Positions Supervised:  Direct Reports Indirect Reports

Senior Regulatory Affairs Specialiast None

Regulatory Affairs Specialist

 

Working Relationships:

1. Internal Contacts

Interface with Corporate Counsel, department heads and all other levels of management.  Provide and solicit information relating to all regulatory, compliance, new product development, and post market surveillance for products.

 

2.  External Contacts

Interface with FDA, international regulatory bodies, regulatory consultants, statisticians, clinical investigators and industry regulatory associations.  Provide and solicit information relating to all aspects of medical device regulatory compliance.

 

Datascope Corp. offers an attractive compensation and benefits package plus an exciting professional environment.  For consideration, please e-mail your resume with salary requirements to career_opportunities@datascope.com Only those who meet our requirements will be contacted.  BE SURE TO PUT THE REFERENCE CODE IN THE SUBJECT LINE. Datascope Corp. is an equal opportunity employer M/F/D/V.