Intuitive Surgical Careers
Director, Regulatory Compliance
Primary Location: United States-California-Santa Clara County-Sunnyvale
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The Director, Regulatory Compliance Quality Systems will be a key member of the Quality Systems and Compliance leadership team with broad responsibilities. S/he will have the primary responsibility to oversee, establish and maintain ISI’s global compliance program to ensure compliance with global regulatory requirements, international standards, company policies and procedures (includes strategic oversight and management of all facility inspections and audits required by government / regulatory agencies on a global basis.) S/he will provide strategic leadership to ensure an up-to-date understanding of applicable laws and regulations to proactively identify and anticipate risk of non-compliance in a dynamic environment conformance to regulatory requirements, internal processes and policies. S/he will provide quality/compliance guidance management oversight for all elements of the Intuitive Surgical Quality Management System (QMS), which includes design controls, corrective and preventive action, training, document controls, production and process controls, facilities and equipment controls, and material controls through to GMP for all aspects including identification and escalation of quality system and product issues.
Roles and Responsibilities:
Additional responsibilities include, but are not limited to the following:
• Play a key role in developing and managing the company’s regulatory compliance strategy for product issues as well as process/quality system issues.• Ability to understand and interface with regional regulatory counterparts for applying US (FDA), Europe (MDD, CE mark), Canada and global regulatory requirements. Provide strategic and practical guidance on interpretation of regulations• Provide guidance, expertise, and direction to ISI’s cross functional teams on product risk, escalations, compliance actions, and need to perform any corrections or corrective actions• S/he will lead and manage the team to interface and support regulatory compliance related activities for the company (with external resources where appropriate)• Lead and facilitate internal and external audits, including certification, surveillance, facility moves/expansions and establishment registrations• Lead and oversee efforts to remediate issues resulting from regulatory assessments (Notified Bodies nonconformity, 483, etc)• Lead Management Review to ensure comprehensive and adequate review of quality data and overall health of Quality Systems• Act as SME and provide training/consultation to internal customers on applicable regulatory requirements (proactively and reactively)• Help proactively monitor changes in regulatory environment, changes in regulations and standards and help communicate and train the rest of the organization• Key member of escalation and investigation teams to understand, interpret and provide guidance on the required compliance actions and measures
• A minimum of a Bachelor’s Degree is required. An Engineering, Science, Mechanical or Electrical Engineering degree is preferred.
• A minimum of 10 years’ experience in a Medical device setting, with a minimum of 5 years in role with responsibility for quality and compliance OR a Masters’ degree and a minimum of 6 years’ experience in a Medical device setting
• 4+ years’ management experience- Demonstrated leadership ability and experience. Demonstrated ability to self-motivate
• Experience working directly with the FDA, Notified Bodies and other governmental agencies on Regulatory matters on a global basis.
• Working knowledge/experience (interpreting and implementing) of risk management practices, Corrective and Preventative Actions and regulatory requirements such as FDA QSR’s, ISO 13485, Annex II of the European Medical Device Directive, CMDR, MHLW Ordinances, Korea GMP Regulations, TGA and external regulatory body’s audits is required.
• Demonstrated strong interpersonal skills and a passion for developing teams and people to their highest potential is required. Demonstrated ability to effectively collaborate and partner with all levels of management while maintaining an appropriate objective focus
• Strong organizational, written and verbal communication skills and the proven ability to prioritize tasks effectively in a deadline-driven environment
• Critical thinking skills and a passion to work in a fast paced industry with complex/cutting edge technology Working knowledge of project management tools and techniques is desirable
• RAC certification, ASQ - CQA, CQE or SCQE, and/or ISO Lead Assessor is desirable