Bedford, MA • Regulatory Affairs
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.
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.
- 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
Job Type : Full-Time
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Experience Level : ""
Job Function : ""