Regulatory Affairs Specialist- Product Development

Overview

Demant is a world‑leading hearing healthcare group that for more than a century has played a vital part in developing innovative technologies and know‑how to help improve people’s hearing and health. In every aspect, from hearing devices, hearing implants and diagnostic equipment to intelligent audio solutions and hearing care all over the world, Demant is active and engaged. The Demant group covers five business areas:
Hearing Care, Hearing Aids, Hearing Implants, Diagnostics, and Communications. We are looking for an experienced Regulatory Affairs Specialist‑Product Development. The Regulatory Affairs Specialist - Product Development is responsible for ensuring products comply with all applicable regulatory requirements, including FDA, EU MDR, and ISO 13485. This role supports product development and serves as a key resource for regulatory guidance throughout the design process.

• Medical, dental, prescription, and vision benefits
• 24/7 virtual medical care
• Employee Assistance Program for you and your family
• 401(k) with company match
• Company‑paid life insurance
• Supplemental insurance for yourself, your spouse/partner, and your children
• Short‑term and long‑term disability insurance
• Pre‑tax Health Savings Account and Flexible Spending Accounts for Health Care or
• Dependent Care
• Pet Insurance
• Commuter accounts
• Employee Perks (tech discount)

• Participate in product development projects to define and document device classification and support the project team in defining user needs, design inputs and applicable General Safety & Performance Requirements (GSPRs).
• Serve as the primary regulatory affairs contact in cross‑functional project meetings and provide guidance on compliance‑related activities.
• Support Regulatory Affairs Development team members in areas such as risk management, usability engineering, electrical safety, and biological evaluation.
• Collect all necessary regulatory documents and prepare the Technical Documentation File.
• Ensure a smooth transition of regulatory responsibilities to the Regulatory Affairs Lifecycle team for post‑market maintenance.
• Regulatory Strategy & Development Support
  • Develop and maintain regulatory plans and strategies for new products, including approval pathways (CE, FDA) and timelines for regulatory activities.
  • Support in defining Intended Purpose.
  • Define and structure Technical Documentation Summary (TDS), including STED files.
• Project & Documentation Ownership
  • Act as RA point of contact in R&D projects within Design and Development process.
  • Document device classification, including system and procedure packs justification.
  • Document Labeling Specification / Design Input.
  • Prepare UDI Data Element document.
  • Ensure usability process is followed.
  • Support device risk management activities.
  • Ensure compliance with applicable GSPR.
  • Identify and specify applicable standards.
  • Ensure regulatory handover from RA Development to RA Lifecycle.
  • Review and approve device documentation including User Needs, Design Inputs and V&V documentation.
  • Ensure preparation of country‑specific documentation.
  • Coordination with test laboratories including electrical safety/EMC testing where applicable.
• Technical Documentation & Submissions
  • Lead 510(k) submissions preparation.
  • Review quality agreements (in collaboration with QA).
• Material Compliance
  • Review and approve new materials purchased in relation to material and chemical compliance.
  • Identify and interpret applicable material and chemical regulations.
  • Contact with biological evaluation laboratories.
  • Support implementation of material compliance according to process defined by global Regulatory Affairs and act as point‑of‑contact regarding material compliance for North America distribution.
• Third‑Party & Distributed Devices
  • Ensure regulatory compliance of third‑party finished products in coordination with global supply chain.
  • Conduct regulatory reviews of distributed and imported devices.
• Clinical Investigation Support
  • Act as Deputy Person Responsible for Regulatory Compliance (PRRC) for clinical investigations.
• All other duties as assigned.

• Proven experience leading compliance projects related to product…