The Regulatory Affairs Specialist (Innovation) is responsible for providing regulatory guidance, developing regulatory strategies, and conducting risk assessments, to new product development (NPD) teams for in vitro diagnostic (IVD) devices, automated laboratory systems, and related software products. This position will be responsible for preparing FDA submissions, including, but not limited to: Pre-IDEs, PMA, PMA Supplements, De Novo Petitions, 510(k) submissions, and CLIA Waiver applications, as well as EU IVDR Technical Files/Dossiers. 

The ideal candidate is an adaptable and solution-oriented professional with experience in regulated healthcare products who is excited by innovation and continuous learning. The ideal candidate enjoys collaborating with scientists, engineers, clinicians, and business leaders to solve complex problems and guide products through development and regulatory approval.  

Responsibilities: 

• Serves as Regulatory Affairs SME on various new product development (NPD) teams 

• Works cross-functionally with R&D, Medical Affairs, Quality, Marketing, Program Management and other key organizational functions 

• Recognizes and addresses potential regulatory risks with project plans 

• Responsible for organizing and leading various FDA & EU IVDR submissions 

• Serves as contact to FDA and Notified Body review teams during submission reviews/communication 

• Recognizes and proposes continuous process improvements. 

Required Education and Experience: 

• Bachelor’s degree in Regulatory Affairs, Life Sciences, Biomedical Engineering, Pharmacy, or related scientific/technical discipline  

• 2-5 years of directly related regulatory experience in the in vitro diagnostic device and/or medical device area(s) (relevant experience in IVDs,  medical devices, laboratory systems, or related regulatory healthcare technologies within a quality or technical position may be considered)  

Preferred Skills and Experience: 

• Demonstrated experience in interpreting subjective and complex aspects of specific regulations 

• Demonstrates in-depth understanding of advanced technical/scientific principles that relate to multiple, diverse, and or complex product lines or manufacturing processes 

• Demonstrated success in supporting product development and product support projects, including complex projects involving ambiguity and rapid change 

• Demonstrated success in preparing, filing and/or completing (including negotiations) regulatory submissions, preferably as primary author 

• Experience with IVDs is desirable, but we also welcome candidates from medical device, digital health, software, or other regulated healthcare backgrounds who are eager to apply their expertise to next-generation diagnostic technologies 

Skills:

• Ability to analyze complex issues and to formulate sound approaches to resolving/addressing issues 

• Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices 

• Ability to handle multiple tasks and to prioritize and schedule work to meet business needs.  Minimal supervision required. 

Technical & Functional: 

• Experience coordinating cross-functional inputs (i.e. R&D, Quality, Medical Affairs, Program Management, Marketing) 

• Ability to compile and review documentation to support FDA submissions and EU IVDR documentation 

• Understanding of regulatory submission processes and lifecycle management 

Communication & Collaboration: 

• Strong written and verbal communication skills 

• Experience working with cross-functional, fast-moving teams 

• Confidence in speaking up within cross-functional teams when regulatory risks are present 

Process & Compliance: 

• Familiarity with SOPs, regulatory procedures, and quality systems (e.g., ISO 13485) 

• Ability to identify and support process improvements 

Other: 

• Strong organizational skills and ability to manage multiple submissions/projects simultaneously 

• Adaptability to changing timelines and priorities 

• Proficiency in Microsoft Office tools (Excel, Word, PowerPoint) 

We prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

For certain roles, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with our Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.