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Senior Manager of Regulatory Affairs

Headhunters, LLC
Gaithersburg, Maryland, United States
October 13, 2018


Headhunters, LLC is seeking a Senior Manager of Regulatory Affairs for our client's Maryland location.

The key responsibilities of the position are to:

•Represent Regulatory Affairs on interdepartmental teams for projects with Operations, Development, QA, Marketing, and other functions as required.

•Manages IVD product strategies for submissions, registrations, and maintenance globally

•Prepare regulatory submissions for US (e.g. 510k, PMA) and Health Canada (e.g. Class III) approvals for IVD products including reagents and instrumentation/software

•Prepare technical documentation needed to demonstrate compliance with applicable European Directives

•Interface with Regulatory Agencies for inquiries/issues and provide support in customer facing issues

•Represent Regulatory Affairs during management of the IVD product change process

Position Requirements

•Minimum Bachelor’s Degree in a scientific discipline

•Minimum 5 years experience in a regulated industry, with at least 3 years experience in Regulatory Affairs preparing US FDA 510(k) and/or PMA submissions, preferably IVD experience

•Demonstrated organizational, planning and prioritizing abilities are required, as well as strong technical writing ability

•Demonstrated strong attention to detail; ability to work under pressure to meet deadlines

•Ability to work on complex problems and exercise sound science-based decision making in developing regulatory strategies and solutions to regulatory problems.

•Flexibility to adjust to changes in schedule, priorities, product availability and perform multiple tasks simultaneously

Personal Requirements

•Good verbal and written skills, working knowledge of MS-Word, Excel and/or Access

•Command of the spoken and written English language is required.

•Must be articulate and able to communicate effectively with employees at all levels of the organization on the telephone and in person as well as with key individuals outside the organization, e.g. FDA reviewers, consultants.

Please send your resume and cover letter to Meredith: