Quality and Regulatory Compliance Specialist - (US-MA-Southboro - 01772)

Minimum Education: None
Jobcode: L:95350912
Email this job to yourself or to a friend

 




ESSENTIAL DUTIES AND RESPONSIBILITIES
 
 

Review labeling materials to assure the company is in compliance with all federal, state, and international labeling requirements. Labeling materials include labels, instructions for use, promotional brochures, sales training materials, and labeling information posted on company websites (internal and external); m onitor company activities to ensure compliance with all labeling process requirements
Conduct, and report internal audits as scheduled in accordance with QSR, CFR, CE/EN and other relevant standards .
Follow up resolution of internal audit findings and external audit findings through the Corrective and Preventive Action program.

Assist with analysis, trending  and reporting of Corporate Internal Audit and External Audit findings.


Assist with regulatory inspections by regulatory agencies and responding to them.

Assist in supporting manufacturing, engineering, quality assurance, product development, and clinical affairs as required to assure regulatory compliance.
Assist with carrying out recall plans and the tracking and reporting of responses to recalls
Assist in the development and review of quality system procedures as they relate to compliance.
Assist in the upkeep and maintenance of EU technical files.

 




 



 
 
 
 
 
 
 











EDUCATION AND/OR EXPERIENCE
BS/BA required, preferably in engineering or life sciences.  Quality and Regulatory compliance experience in the Medical Device industry is mandatory [minimum 3 years preferred].  You must be able to communicate effectively (verbal and written) and be proficient in Microsoft Office (Word, Excel or Access, PowerPoint). 




CERTIFICATES, LICENSES, REGISTRATIONS
Auditor certification (i.e. CQA, CBA, RAB) or equivalent experience is required. Documented continuing education in regulatory affairs or RAC Certification is a plus.