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Manager, Regulatory Affairs

Headhunters, LLC
Gaithersburg, Maryland, United States
December 07, 2018


Headhunters, LLC's client is seeking a Manager of Regulatory Affairs to develop regulatory strategies for new and modified in vitro diagnostic (IVD) products.

- Prepare regulatory submissions for US and Health Canada approvals for IVD products that include test kits for women's health, immune response kits for transplantation.

- Research and interpret regulations, guidelines and precedents to support interdepartmental project teams in developing strategies, policies and procedures that ensure regulatory compliance with FDA, Health Canada and other regulatory agencies in the least burdensome manner.

- Interface with regulatory agencies for inquiries and issues.

- Review R&D protocols and technical reports and other company documents (including labeling and marketing materials, when applicable) for use in regulatory submissions and in response to queries from the FDA and Health Canada.

- Responsible for ensuring on-going compliance to applicable quality and EHS regulations and standards (e.g., ISO, US FDA, MDD, IVDD, EU-PSHA, OSHA, etc.).

Position Requirements

- Minimum Bachelor’s Degree in a scientific discipline.

- Molecular biology or clinical laboratory experience would be a strong asset in the position.

- RAC certification preferred, but not required.

- At least 4 years’ experience in the medical device, pharmaceutical or biologics industry, with at least 2 years’ experience in Regulatory Affairs preparing 510(k) and/or PMA submissions, preferably in the area of IVDs.

- Demonstrated strong attention to detail, as well as the ability to work under pressure to meet project deadlines.

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

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

- Knowledge of German would be very helpful, but not required.

- Able to communicate effectively with employees at all levels of the organization as well as with key individuals outside the organization. These outside contacts may include FDA reviewers, consultants, and representatives from clinical sites or other IVD or pharmaceutical companies.

- Moderate travel required.

Personal Requirements

- Must have strong interpersonal and communication skills with strong English language ability.

- Thrive in a fast paced work environment, while possessing the ability to quickly change priorities and perform multiple tasks simultaneously

Please email your resume and cover letter to Meredith: