Senior Regulatory Affairs Specialist

Scope of the Job:

The Senior Regulatory Affairs Specialist is located in the Mountain States Region and reports to Manager of Regulatory Affairs. A generous relocation package is available. Your basic role is the overall coordination and preparation of Investigational Device Exemption (IDE) Protocols between medical affairs and the product teams. You will write the IDE and aid with its implementation. You may work with contract research organizations to develop and implement clinical trial protocols.

Responsibilities:

Serves as Regulatory Affairs representative on product teams as assigned.

Signs test protocols and reports as required.

Develops and administers new product field trials as required.

Coordinates the collection of data and information for regulatory submissions; writes required regulatory submissions for new company's products.

Performs GMP/ISO 9000 audits as requested by department head.

Performs ECN review and sign-off for any "special orders" for compliance with FDA custom device policies as well as update RA database of special orders.

Performs special projects, such as administering recalls, as required by Department Head.

Provides RA with FDA device listing/registration information.

As requested, serves as alternate FDA inspection coordinator.

Prepares and submits PMA annual report and signs-off PMA related ECNs. Serves as the company's international information contact person, coordinates the preparation of international dossiers with the assigned product teams and updates them as required. Develop and maintain MDR and vigilance reporting paradigm.

Must be extremely flexible and able to rapidly change priorities.

Must have the ability to develop solutions and solve problems for a wide variety of situations as they arise.

Must have medical and technical aptitude.

Must have technical writing skills.

A comprehensive knowledge of ISO, GCP, FDA, and other applicable regulations governing the conduct of clinical trials us required.

Exposure to IDE's and PMA's.

Candidates should have the ability to interact effectively with others in our business, with our customers, and with others externally.

Must be computer literate and familiar with Windows, Word, and PowerPoint.

A minimum of 1-year clinical research experience.

Bachelors Degree in life, law or engineering science field.

Five or more years experience in class II or II medical devices.

Compensation