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.
Works cross-functionally with R&D, Medical Affairs, Quality, Marketing, Program Management and other key organizational functions
Required Education and Experience:
Bachelors 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:
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
Experience coordinating cross-functional inputs (i.e. R&D, Quality, Medical Affairs, Program Management, Marketing)
Communication & Collaboration:
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.
Primary Work LocationUSA MD - Sparks - 7 Loveton Circle
Additional Locations
Work Shift
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Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.
Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.
Salary Range Information
$95,900.00 - $153,400.00 USD Annual
