Director, Product Compliance & Risk Management at AbleNet

Roseville, Minnesota, United States -

Full Time

Start Date

Immediate

Expiry Date

11 Feb, 26

Salary

0.0

Posted On

13 Nov, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Compliance, Risk Management, Medical Device Regulations, ISO 13485, Product Safety Certifications, Technical Documentation, Cross-Functional Collaboration, Analytical Skills, Organizational Skills, Communication Skills, Post-Market Surveillance, Complaint Handling, Leadership, Quality Management, Contingency Planning, Global Compliance

Industry

Medical Equipment Manufacturing

Description

POSITION SUMMARY: The Director, Product Compliance & Risk Management will lead AbleNet’s product-based compliance strategy and risk management across all markets. This position ensures that all AbleNet products, hardware, software, and accessories—meet the applicable medical device requirements in the United States (FDA), European Union (MDR 2017/745), United Kingdom (UKCA), and Switzerland (MedDo). This leader will oversee the global compliance lifecycle, from design and documentation through post-market surveillance, and ensure that AbleNet’s products consistently meet international standards for safety, quality, and performance. The Director, Product Compliance & Risk Management, is additionally responsible for outline, monitoring, and developing a product risk plan so we can better respond to potential issues that may arise in supporting our future, current, and past customers using AbleNet product solutions. This role requires embracing technology, a commitment to regulatory compliance and nimbleness, demonstrates a strong sense of urgency, and aligns with AbleNet’s guiding principles, 7-Rules of Engagement, and 5-Tenets of Leadership. POSITION RESPONSIBILITIES: * Serve as AbleNet’s subject-matter expert on global medical device regulations, including: 1. FDA (21 CFR 820 & related medical device requirements) 2. EU MDR (2017/745) 3. UKCA medical device regulations 4. 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. CORE COMPETENCIES, SKILLS, & ABILITIES * 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. POSITION REQUIREMENTS: Education & Experience * 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 Physical, Time, Presence & Other Requirements Physical: Up to 8 hours of computer keyboarding and handling customer correspondence via phone, emails, chat, and/or video conferencing Time: Full-Time, Exempt employees work an average of 40 hours per week. Additional hours may be required as necessary. Presence: This role can be performed in an onsite, hybrid, or fully remote capacity. Travel: Up to xx% of domestic travel may be expected

Responsibilities

The Director will lead AbleNet’s product compliance strategy and risk management, ensuring all products meet applicable medical device requirements across various markets. This role includes overseeing the global compliance lifecycle and developing a product risk plan to address potential issues.