Regulatory Specialist

POSITION SUMMARY/ROLE AND RESPONSIBILITIES:

• Support in the preparation/submission of robust regulatory applications in accordance with organizational objectives
• Create, review, and approve engineering change orders
• Act as a regulatory representative on product development teams, communicate regulatory requirements •
• Provide guidance and expertise on – risk analysis, quality system requirements, verification/validation testing, biocompatibility etc.
• Maintain ongoing surveillance and analysis of pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current, and up to date
• Support implementation of Quality Management System
• Conduct internal/supplier audits

WORKING CONDITIONS: Typical office work related activities.

Requirements: 

QUALIFICATIONS AND EDUCATION REQUIREMENTS

• BA or BS degree; Scientific or engineering field preferred.
• 2-4 years of technical experience, including at 1+ years of regulatory experience in a medical device industry
• Experience with 510(k) applications, PMA supplements and US device regulations and/or experience with EU and other international medical device regulations and submissions
• Must have knowledge of U.S. and/or European/International regulations and standards
• Experience in preparing regulatory submissions.

KNOWLEDGE/SKILLS: 

• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
• Must demonstrate good technical writing skill
• Must work well in team environments • Proficient on programs under Microsoft office; proficient in formatting submission documents
• Proven analytical abilities
• FDA 510k, PMA regulations
• EU MDR requirements

PREFERRED SKILLS: RAC Certification

Send cover letter and resume to Janet Desaulniers