Lead and execute regulatory strategy for implantable neurostimulation therapy for obstructive sleep apnea, supporting global regulatory activities in the U.S. and EU.
Compensation
$110,000—$150,000 USD
Responsibilities
Serve as a strategic regulatory partner to cross‑functional teams
Assess regulatory impact for new product development and post‑market changes
Develop and communicate regulatory pathway options
Compile, prepare, review, and submit high‑quality regulatory submissions in the U.S. and EU
Collaborate with subject matter experts to respond to regulatory authority questions
Requirements
Bachelor's degree in engineering, life sciences, or related scientific discipline
Nice to have: medical device industry experience
Nice to have: quality
Nice to have: engineering
Nice to have: software regulated as a medical device
Supports the creation and ongoing maintenance of the 2-100 Small Group, AFA and IVL conversion prototype controls for both Traditional and HNO products by utilizing the Small Group product database/general report and plan set up resources. Set up plans using a prototype control in CCI and PMA application to support the Small Group plans set up case install automation process.
Compensation
The typical pay range for this role is: $22.59 - $58.85. This pay range represents the base hourly rate or base annual full-time salary for all positions in the job grade within which this position falls.
Responsibilities
Supports the creation and ongoing maintenance of the 2-100 Small Group, AFA and IVL conversion prototype controls for both Traditional and HNO products
Set up the plans using a prototype control in CCI and PMA application to support the Small Group plans set up case install automation process
Prioritize, meet and/or exceed deadlines
Prompt handling of all-time sensitive Compliance, Department of Insurance, Claim Issues and Legislative requests
Perform research, interpretation, and problem-solving
Requirements
High School Diploma or equivalent
Nice to have: Former Traditional Plan Coordination Consultant experience
Nice to have: Case Installation experience
Nice to have: Proficiency in Aetna/CVS products and programs
Provides strategic and operational leadership for the Regulatory Affairs function across the business area, accountable for establishing global regulatory strategy, securing market access, and leading regulatory remediation.
Locations (2)
Wayne, New Jersey, United States
Europe
Compensation
compensation based upon location
Responsibilities
Provide strategic leadership and direction for the Surgical Workflows Regulatory Affairs function.
Define and implement regulatory objectives aligned with the Surgical Workflows strategy, portfolio and business priorities.
Establish a clear global regulatory strategy covering new products, existing products, portfolio changes and market access.
Monitor the global regulatory environment and translate emerging requirements into clear business actions and priorities.
Lead and manage the Regulatory Affairs teams across Surgical Workflows.
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