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Manager, Regulatory Affairs

Company:
Headhunters, LLC
Location:
Germantown, Maryland, United States
Salary:
DOE
Posted:
November 09, 2018

Description:

Headhunters, LLC's client is seeking a Regulatory Affairs Manager.

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 and issues.

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

Requirements:

- Minimum Bachelor’s Degree in a scientific discipline.

- Minimum 4 years experience in a regulated industry, with at least 2 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.

- 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.