As a Sr. Regulatory Affairs and Quality Assurance Specialist with this growing manufacturer of innovative orthopedic implant devices, you will be responsible for FDA regulatory submissions, EU technical file creation and maintenance, periodic updates and registrations to regulatory agencies; as well as, the administration of the company’s quality management system. You will participate in various company activities as the QA/RA representative, providing guidance on US and international regulatory requirements, and development of regulatory strategy for future products.
- MUST HAVE a minimum of 6-10 years experience working with FDA regulated medical devices (Class II minimum)
- MUST HAVE a minimum of 3-5 years experience authoring FDA medical device regulatory submissions (510(k), PMA, IDE, De Novo)
- MUST HAVE experience in determining the testing requirements for biocompatibility, mechanical and other performance tests related to implantable devices
- MUST HAVE experience developing SOPs, work instructions and other supporting documents to address domestic and international regulatory requirements.
- Demonstrated working knowledge and a history of successfully implementing quality system elements, including, but not limited to: CAPAs, product complaints, design controls, quality system audits, document change controls, employee training, process and software validation.
- Ability to exercise independent judgement within defined procedures and practices to determine appropriate action.
- Ability to provide guidance and training to company peers
- Ability to travel domestically (~10%) to conduct periodic supplier audits
- Bachelors degree in science, engineering or technical field
- Working knowledge of FDA medical device regulations, guidance documents, recognized consensus standards
- Ability to manage multiple projects simultaneously
- Excellent written and verbal communication skills
- Excellent organizational skills
- Familiarity with QMS software packages such as: MasterControl, TrackWise, AssurX, etc.
- MS Office Suite (Word, Excel, Project, Access, PowerPoint, Visio)
- Statistical S/W (MiniTab, JMP or equivalent)
- RAC, ASQ CQE, CQM, or CQA desired
- Six Sigma Green or Black Belt desired
Job Type: Full-time
Required work authorization: