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Senior Specialist Regulatory Affairs

Headhunters, LLC
Gaithersburg, Maryland, United States
November 02, 2018


Headhunters, LLC's client is seeking a Senior Specialist, Regulatory Affairs in Maryland.

Position Description

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

- 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.

- Represent Regulator Affairs during management of the IVD product change process.

Position Requirements

- Associate, BA or BS degree, preferably in a math or science field.

- 510k submission experience.

- 2-5 years’ experience in a regulated industry.

- IVD experience is preferred.

- Project development experience.

- Demonstrated organizational, planning and prioritizing abilities are required.

- Must have strong attention to detail; ability to work under pressure to meet deadlines.

- Flexibility to adjust to changes in schedule, priorities, product availability.

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

- PMA submission experience is helpful.

Personal Requirements

- 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.

- Travel – 20%

Please email your resume and cover letter to Meredith: