Regulatory Affairs Specialist (Innovation)

Regulatory Affairs Specialist (Innovation)

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) 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.

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 (Equivalent combination of education and relevant experience may be considered)
• Minimum 5 years of directly related regulatory experience in the in vitro diagnostic device and/or medical device area(s)

Preferred Skills and Experience:

• RAPS Certification preferred
• 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

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)
• Remote opportunity for the right individual