Regulatory Affairs Specialist- Product Development

Demant•Eden Prairie, MN

About The Position

Diagnostic Group, LLC is part of the Demant Group. 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. Diagnostic Group, LLC is looking for an experienced Regulatory Afffairs 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.

Requirements

Proven experience leading compliance projects related to product certification, regulatory changes, and audits.
Demonstrated ability to drive accountability across functions to ensure compliance and product safety.
Strong knowledge of FDA regulations, EU MDR, and ISO 13485 standards.
Strong expertise in medical device classification and regulatory pathways.
Proficiency in preparing and managing Technical Documentation Files.
Ability to interpret and apply General Safety & Performance Requirements (GSPR).
Understanding of material and chemical compliance regulations.
Excellent analytical and problem-solving skills, with the ability to troubleshoot complex systems.
Excellent written and verbal communication skills for cross-functional collaboration.
Strong organizational skills and attention to detail.
Ability to manage multiple projects and meet strict deadlines.
Proficiency in regulatory documentation tools and systems (e.g., UDI databases, labeling systems).
Ability to work independently and as part of a team in a fast-paced environment.
Bachelor’s degree in a scientific, engineering, or regulatory-related field preferred and a minimum of 5 years of experience in Regulatory Affairs/Product Compliance OR a high school diploma (or equivalent) with an equivalent combination of education, training, and experience, including at least 10 years in Regulatory Affairs/Product Compliance.
Experience supporting product development and regulatory submissions.
Experience with international regulatory requirements and documentation standards.

Nice To Haves

Knowledge of international electrical safety/EMC standards (IEC 60601) for medical electrical equipment preferred.

Responsibilities

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.
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.
Act as RA point of contact in R&D projects within Design and Development process.
Document device classification, including system and procedure packs justifications.
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.
Lead 510(k) submissions preparation.
Review quality agreements (in collaboration with QA).
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.
Ensure regulatory compliance of third-party finished products in coordination with global supply chain.
Conduct regulatory reviews of distributed and imported devices.
Act as Deputy Person Responsible for Regulatory Compliance (PRRC) for clinical investigations.
All other duties as assigned.

Benefits

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)