Senior Regulatory Affairs Specialist

Scope of the Job:

The Senior Regulatory Affairs Specialist is located in Covington, Georgia and reports to the Manager of Regulatory Affairs. You will be responsible for domestic and international device submissions.

Responsibilities:

Provide regulatory support of product project teams (e.g., developing regulatory strategies, timeline development, and reviewing submission related documents)

Prepare and audit 510(k)s, IDEs, PMAs? and/or international submissions as required.

Provide technical interface with FDA and international reviewers and respond to questions.

Provide the appropriate information to support international product registrations.

Provide timely review and approval of product labeling for regulatory compliance.

Provide support required for CE marking activities, including preparation and maintenance of product technical files.

Prepare Canadian submissions as required.

Mentor and train Regulatory Specialists.

Candidate Requirements:

BS or BA degree in technical area such as biology, chemistry, physiology, engineering, medical or law.

Five years minimum experience in Regulatory Affairs for Class II and Class III medical devices and/or pharmaceuticals.

Regulatory Affairs Certification (RAC)? desired.

Prior supervisory experience a plus.

Must have excellent written and verbal communication skills.

Must be a team player.

Must be able to prioritize and handle several projects concurrently.

Must be self-motivated by working independently and having the ability to take ownership of her/his responsibilities.

Must be computer literate.

Must be able to meet goals on time.

Must have knowledge of the U.S.A. Federal Regulations for medical devices including those applicable to the import/export of devices.

Must have knowledge with the requirements for medical device registration/licensing in the EU,Japan, Canada, Australia, Latin America and Asia/Pacific.

Compensation:

A compensation package will be designed to attract outstanding talent and will include a base salary, performance bonus, and an attractive benefits package.