Senior Regulatory Affairs Program Specialist

ZOLL

Chelmsford, MA, United States
On-site
Medical device manufacturing
Regulatory requirements
Product development lifecycle
ZOLL is seeking a Senior Regulatory Affairs Program Specialist to lead regulatory compliance initiatives in the Acute Care Technology division. The ideal candidate will have extensive experience in the medical device industry, particularly with regulatory authorities, and will play a key role in ensuring the company’s products meet all necessary regulatory requirements

Job Summary

  • The Senior Regulatory Affairs Program Specialist is responsible for leading the collaboration with cross-functional stakeholders to ensure regulatory compliance is met.
  • This role will act as the technical liaison between cross-functional departments and the Regulatory Affairs team, evaluating and resolving regulatory and technical issues.
  • Key responsibilities include leading compliance initiatives, assessing technical guidelines, driving education, and serving as a product technical subject matter expert for global market entry.

Matching Summary

Match Score: 85

ZOLL is seeking a Senior Regulatory Affairs Program Specialist to lead regulatory compliance initiatives in the Acute Care Technology division. The ideal candidate will have extensive experience in the medical device industry, particularly with regulatory authorities, and will play a key role in ensuring the company’s products meet all necessary regulatory requirements.

Skills & Requirements

Must-have

  • medical device manufacturing
  • regulatory requirements
  • product development lifecycle
  • technical medical device compliance
  • pre-market requirements
  • global regulatory submissions
  • change requests
  • risk management plans
  • hazard analysis
  • design documentation

Nice-to-have

  • improving patient outcomes
  • innovative technologies
  • world-class customer service
  • entrepreneurial spirit
  • analytical abilities
  • problem-solving skills
  • interpersonal skills
  • leadership skills

Key Requirements

  • Bachelor's Degree required
  • 5+ years of regulatory experience in the Medical Device Industry required
  • Previous experience working with Regulatory Authorities required
  • Experience interacting with FDA and/or other regulatory agencies
  • Proven ability to prioritize, conduct, and manage time

Work Rights

Not specified

Tailored Resume

Cover Letter