Senior Compliance Engineer/Specialist will provide expertise and support to run efficient, effective and sustainable processes to ensure on-going compliance with domestic and international regulations and standards. S/he will ensure overall Quality Management System (QMS) compliance and ensure an up-to-date understanding of applicable laws and regulations so that the company's risks are identified and managed appropriately.
Roles and Responsibilities:
- Help provide guidance on a variety of ad-hoc compliance questions, including helping research the regulations, current process/practices within ISI, industry/regulatory agency expectations etc.
- Provide guidance, review and approve various documents on behalf of Reg. Compliance, ranging from customer facing materials, technical bulletins, QS procedures, facility moves and establishment registrations etc.
- Establish and prepare Quality Review Board metrics for the Regulatory Compliance group.
- Help coordinate Quality Review Board and Management Review meetings, work with cross functional teams to coordinate/summarize the data, key takeaways and actions
- Bachelor's Degree in a scientific or other relevant field is preferred.
- 6+ years of experience in Quality, Compliance or Regulatory role in the medical device industry is required.
- Ability to understand the regulations and help interpret it for the company. Working knowledge of implementing, and providing guidance on domestic and international regulations
- Applied understanding of QSRs, cGMP, ISO 13485, ISO 14971, European Medical Device Directive, Canadian Medical Device Regulations (CMDR) etc.
Sthree US is acting as an Employment Business in relation to this vacancy.