AbleNet, Inc. · 2 months ago
Director, Product Compliance & Risk Management
Roseville, MN, US
Full-time
Hybrid
Director/Executive
$172K/yr - $195K/yr
10+ years expAbleNet, Inc. is a company focused on ensuring product compliance and risk management in the medical device sector. The Director, Product Compliance & Risk Management will lead the compliance strategy and oversee the global compliance lifecycle for AbleNet’s products, ensuring they meet international safety and quality standards.
Medical Device
Responsibilities
Serve as AbleNet’s subject-matter expert on global medical device regulations, including:
FDA (21 CFR 820 & related medical device requirements)
EU MDR (2017/745)
UKCA medical device regulations
Swiss MedDo
Understanding of ISO 13485 for quality management systems for medical devices
Lead product-based risk management strategy and develop recommendations that help to mitigate risk
Ensure regulatory compliance for all product classes, labeling, technical documentation, and declarations of conformity
Lead communications with regulatory authorities, notified bodies, and authorized representatives in each market
Monitor and interpret changes in global regulatory frameworks; proactively update internal policies, processes, and documentation
Establish and maintain AbleNet’s global compliance management system integrated with design controls and risk management processes
Oversee product safety certifications (e.g., FCC, RED, IEC 60601/62368, RoHS, REACH, CPSIA) and coordinate with third-party testing labs
Collaborate with Product Development and Quality teams to ensure compliance is considered from concept through post-market
Ensure all labeling, instructions for use, and packaging meet regulatory and language requirements for each region
Oversee post-market surveillance, complaint handling, and field safety corrective actions as required by global regulations
Build and lead a small global compliance team or manage external compliance partners
Collaborate with internal teams (Product Management, Operations, Supply Chain, Quality, and Legal) to integrate compliance into daily business decisions
Advise leadership on compliance issues & risk, mitigation strategies, and long-term regulatory implications for new products and markets
All other duties as assigned by manager
Qualification
Required
Master's degree in Engineering, Regulatory Affairs, Quality Management, or related field (advanced degree preferred)
10+ years of experience in medical device regulatory or product compliance, including leadership responsibility
Regulatory Affairs Certification (RAC) or similar credential strongly preferred
5+ years of experience in managing product risks and contingency planning
Demonstrated expertise with FDA, EU MDR, UKCA, and Swiss MedDo regulatory frameworks and ISO 13485
Experience managing device classifications, technical documentation, and conformity assessment routes (CE, UKCA marking, FDA listing)
Familiarity with global safety and environmental compliance standards (RoHS, REACH, IEC, FCC, RED, CPSIA)
Proven ability to collaborate cross-functionally and communicate regulatory requirements clearly to technical and non-technical teams
Exceptional organizational, analytical, and documentation skills
Company
AbleNet, Inc.
At AbleNet, we believe everyone deserves the tools to thrive.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Adam Wing
Chief Revenue Officer (CRO)
Company data provided by crunchbase