Job Description

Job Title:   Regulatory Affairs Specialist

Department:   QA/RA

Supervisor:   QA/RA Manager

Position Summary

The Regulatory Affairs Specialist compiles and maintains regulatory documentations for submission and registration of the medical device products. The RA Specialist ensures that all necessary documents are filed and handled in accordance with international and domestic regulation authorities. This position is responsible for registration of the corporate products and requires the ability to multitask and manage multiple deadlines competently.

Duties

• Compile and maintain regulatory documentation databases or systems.
• Gather necessary paperwork and documentation for regulatory filings.
• File submission renewals as needed.
• Keep track of the progress of regulatory submissions, if necessary, once they're submitted to the regulatory agency.
• Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes
• Coordinate, prepare, or review regulatory submissions for domestic or international projects
• Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
• Attend continuing education courses as often as necessary to keep current on changing regulatory policies and procedures
• Prepare or maintain technical files as necessary to obtain and sustain product approval
• Write or update standard operating procedures, work instructions, or policies

Qualification and Experience Requirements

• Knowledge and prior experience in FDA, ISO and applicable regulations and guidelines are required.
• BS/BA in Biology or related field is recommended.
• Knowledge of medical device manufacturing processes is preferred.
• Excellent communication skills and the ability to work well with people at all levels are essential.
• Must have strong organizational, analytical, problem solving, and management skills.
• Experience with MS-Office (especially Excel, Word) is needed.