Auditing & Compliance Director – Software as a Medical Device (SaMD)

LOCATION: Hybrid – 8 days a month in the office (see approved locations on the posting).

OVERVIEW

You will be the global product quality lead in support of a broad portfolio of on-market medical devices including Software as a Medical Device (SaMD) within the Health Division in Wolters Kluwer. Important responsibilities include cross-functional correspondence, quality management reviews, audit support, change planning, and corrective and preventative action (CAPA)plans, with oversight of complaint trending, post-market surveillance, clinical evaluation, design control, and risk management activities. You will lead and participate in projects to enhance and maintain safety and performance of on-market products, interfacing with supplier and internal groups to drive product quality.

You will work with a core team of subject matter experts but must also work cross functionally within the business teams in Legal, Regulatory, Clinical, Marketing, and Product Development and within the broader Wolters Kluwer business to ensure consistent practices across the company.

You will report to the VP, Clinical Content Management

RESPONSIBILITIES

Quality Management and Compliance

• Maintain and monitor Quality Management System (SOPs/WIs) in compliance with ISO 13485, US Quality System Regulation for SaMD regulated by the FDA, and EU MDR.
• Perform design control activities focused on 21 CFR 820, ISO 13485, and IEC 62304.
• Manage Risk Management Process in compliance with ISO 14971.
• Identify gaps in existing processes and develop new processes.
• Support external and internal audits; represent Quality Assurance as a subject matter expert.
• Assure integration and support of device regulations and compliance with company policies and procedures.

Supplier Management

• Perform supplier management activities, including review and approval of 3rd party design control activities, assess supplier changes, balance internal oversight actions and supplier controls, provide input to quality agreements, develop relationships, and visit supplier sites.
• Support supplier audits as required.

System Testing and Issue Resolution

• Manage and guide system testing activities, including verification and validation.

• Lead resolution of quality issues with on-market device software; drive investigations related to product nonconformities and implement CAPA plans.
• Serve as Quality approver for device software complaints and complaint trend evaluations.
• Review and approve device software design control tasks or IT change requests in Service Now.
• Support risk management/failure effect modes analysis (FMEA) activities for device software.
• Drive change management process for device software launches and market expansions.

Post-Market Surveillance and Regulatory Affairs

• Coordinate post-market activities including surveillance, trend reporting, adverse event reporting, and field safety corrective actions. Serve as Device QA approver for post-market surveillance and clinical evaluation plans/reports for SaMD products.
• Monitor external regulatory trends to anticipate potential business/regulatory risks; communicate risks and lead implementation of regulatory measures.
• Evaluate global regulatory landscape and advise cross-functional teams to ensure product compliance.
• Prepare documentation and third-party testing for US and global registrations, license renewals, new product registrations, and product change registrations.
• Ensure regulatory submissions are well-organized, scientifically accurate, high quality, and facilitate agency review.
• Review design inputs and proposed design changes to ensure regulatory requirements are met.
• Review product labeling and promotional materials for consistency with regulatory clearances.
• Review new/revised regulations/standards; develop internal SOPs, WIs, and policies.
• Continuously pursue regulatory knowledge to gain expertise in product submissions and regulatory topics.
• Coach and mentor internal cross-functional teams on regulatory strategy and risk management.

Collaboration and Strategy

• Foster global collaboration with cross-functional teams to identify and mitigate product risks.
• Partner with internal business partners to solve technical and strategic challenges impacting the device portfolio.
• Build and cultivate strong partnerships with internal business partners.
• Demonstrates continuous pursuit of regulatory knowledge to obtain experience and expertise in product submissions and regulatory topics, including FDA regulations, 510(k)s, labeling and promotional materials, 21 CFR 820, global medical device registration, technical writing, and external standards.

QUALIFICATIONS

Education: Bachelor’s Degree required. Clinical Degree preferred (e.g. PharmD / pharmacist, M.D. / medical doctor, etc.).

Experience:

• 5+ years of quality and risk experience related to software as a medical device sold in the U.S., E.U., and globally.
• Demonstrated comprehensive expertise in the applied interpretation of worldwide regulatory standards and laws applicable to the medical device industry e.g., ISO, QSR, GMP. Must have E.U. MDR and FDA Class II medical device experience, focused on software as a medical device.

Other Knowledge, Skills, Abilities or Certifications:

• Working knowledge of ISO 13485, ISO 14971, IEC 62304, 21 CFR 4, 21 CFR 820, EU Regulation 93/42/EEC (MDD) & 2017/745 (MDR)Thorough knowledge of ISO 13485 quality system requirements.
• Experience compiling and submitting regulatory applications and submissions
• Familiarity with SaMD is preferred.
• Other compliance experience (i.e. EU RED, CPSC, FCC, RCM) preferred.
• Be a detail-oriented with technical writing skills.
• Ability to think critically and strategically, capable of effectively interpreting and communicating the impact of business initiatives, regulations, and industry trends to various stakeholders.
• Possess interpersonal communication, teamwork, and organizational skills, able to build and leverage cross-functional relationships to gather insights and initiative continuous improvement.
• Be a creative problem solver, adept at identifying root causes, evaluating optimal solutions, and recommending comprehensive upgrades to prevent future issues · Lead Auditor Certified, preferred · Regulatory Affairs Certification (RAC), preferred.

TRAVEL: Travel is minimal and tends to be irregular in frequency. The job will involve working with teams remotely on a regular basis. Travel requirements are variable and may include internal meetings, agency meetings, presentations and other travel.

#LI-Hybrid

Applicants may be required to appear onsite at a Wolters Kluwer office as part of the recruitment process.

Compensation: