Regulatory Affairs Specialist

Summary of Position with General Responsibilities:

The Regulatory Affairs Specialist (RAS) demonstrates ability to create and communicate global regulatory requirements throughout the product lifecycle working closely with a cross functional team. The RAS is able to interpret and communicate regulatory changes to ensure the business is aware of opportunities, risks and issues. The RAS is responsible for ensuring compliance with regulations, processes and procedures. The RAS utilizes project planning skills to initiate, plan, execute, and manage regulatory projects and submissions. The RAS manages change and is flexible when providing solutions. The RAS demonstrates collaboration with their regulatory team, cross functional team members, and regulatory agency partners by building strong and effective working relationships.

Essential Job Functions:

1. Understands and has working knowledge of FDA medical device regulations, European Medical Device Directives, and/or other global regulations.
2. Participates in product core teams as required to ensure that the product is in compliance with all internal and external regulatory requirements. Develops, documents and implements a regulatory strategy plan around product development goals.
3. Prepares U.S. FDA submissions (e.g., 510(k), IDE, PMA) as required and per applicable SOPs.
4. Initiates and updates technical files/dossiers/registrations as required and per applicable SOPs.
5. Reviews and approves change orders for compliance with FDA, European and/or global regulations and standards.
6. Ensures adequate documentation of compliance to FDA, European and global regulations and standards. Ensures maintenance of the Regulatory Affairs files.
7. Develops working relationships with key personnel/representatives of the U.S. FDA Offices of Device Evaluation and Compliance and the company's notified body.
8. Works with the regulatory management team to ensure compliance with Corporate Regulatory.

Preferred Experience:

1. Working knowledge of U.S., European and/or global regulations and standards covering medical devices.
2. 4-6 years of RA related experience.

Minimum Qualifications:

1. Bachelor's degree or advanced degree in technical area such as biology, chemistry, engineering or medical-related field.
2. Minimum of 2 years of RA related experience.

For more information and to be considered for this opportunity qualified candidates can apply by following the link provided.

About Aerotek: Aerotek, headquartered in Hanover, Md., is a leading provider of technical, professional and industrial staffing services. Established in 1983, Aerotek is an operating company of Allegis Group, the largest provider of staffing services in the U.S. Aerotek operates a network of more than 200 non-franchised offices throughout the U.S., Canada and Europe. For more information, visit aerotek.com. Aerotek is acting as an Employment Agency in relation to this vacancy.