Medical Device, Quality/Risk Management, Submission & Registration, US Regulatory Affairs
4 Year Degree
About the Regulatory Affairs Specialist Role:
You will be leading cGMP compliance with a team of mechanical engineers, electrical engineers, software engineers, designers, research coordinators, and healthcare professionals. The ideal candidate is a highly intelligent, self-motivated and personable individual looking to build upon their previous Regulatory Affairs experience and help our company organically grow from a small start-up into a company with multiple approved products.
Candidates must be able to effectively communicate regulatory requirements to staff with no regulatory expertise, and to strategically harmonize regulatory requirements with business and research interests. A successful candidate will be relentlessly detail-oriented, while also keeping product vision in mind.
Developing, managing, and maintaining ISO 13485 & FDA Medical Device cGMP-compliant Quality Management System
Preparing FDA filings for novel medical devices
Supporting & guiding engineering, management, and R&D teams with regulatory compliance
Performing risk management activities, adapting and enhancing existing QMS standard operating procedures (SOPs)
Conducting audit readiness activities
Bachelor’s degree (STEM, medical, or law background strongly preferred but not required)
Direct experience with NDA submissions, specifically 505(b)(2) filings, strongly preferred
Submissions involving software, including as a component of medical device, strongly preferred
Strong analytical and technical writing skills
Thorough knowledge of FDA guidance and regulations required. Knowledge of ex-US requirements desirable.
Experience developing and managing Quality Management System (QMS)
Ability to effectively communicate with co-workers using strong verbal and written communication skills
Ability to effectively organize and prioritize tasks to achieve deadlines
Telecommuting is allowed.
Additional Salary Information: Salary commensurate with experience. Competitive benefits include equity opportunities, health insurance, and flexible vacation time.
Internal Number: 13485
MedicaSafe is a small but growing technology company tackling the issue of medication non-adherence in the areas of healthcare with the most pressing needs: opioid use disorder, mental health, and pain management. We have been awarded multiple grants by the National Institutes of Health (NIH) and are partnered with some of the most passionate healthcare providers in the country. Our employees do meaningful work in a creative, pun-filled environment.