Sr. Regulatory Affairs Specialist-Medical Device

Our client is a global leader in the development, manufacturing and marketing of medical devices.  Delivering more than 40,000 products to over 40 countries.

 Job Responsibilities: 
Act as a liaison to facilitate interpretation and application of company policy and procedures
Provide expertise and guidance in interpreting regulations of  FDA and international(EU and Asia) agency guidelines
Research as necessary and keep abreast of all domestic and international regulatory regulations
Identify, create and implement regulatory affairs training
Review corporate labeling and advertising materials
Act as a core team member for corporate projects
Assist in preparation of 510K and PMA submissions
Other responsibilities as assigned

Job Qualifications:
Bachelor?s degree in a scientific or technical discipline
Professional certification(s) preferred
5-8 years Regulatory Affairs medical industry experience
Understanding of FDA and international regulations
Strong working knowledge of medical devices, procedures and terminology
Working knowledge of product development process and design control.
Excellent written and oral communication skills. 

 

Compensation: $73,000.00 (Higher compensation commensurate with experience. Excellent benefits and relocation package)

 

For confidential consideration, please forward your resume in a Word document to