Primary Function of PositionPrincipal-level professional individual contributor leading enterprise-wide or global compliance initiatives. Drives policy, major risk assessments, remediation projects, compliance strategy, audit response, training programs, technology adoption, and business integration activities. Represents the organization in regulatory, client, industry, or executive interactions.
Essential Job Duties - Develop, implement, and harmonize compliance programs, policies, and QMS controls company-wide or globally.
- Lead major risk assessments, gap assessments, company investigations, remediation projects, and CAPA-related compliance programs.
- Guide responses to high-profile regulatory audits, inspections, client reviews, and industry assessments.
- Advise executives on compliance risks, regulatory trends, business impact, and company strategy.
- Lead compliance training initiatives and develop core certification programs.
- Mentor and coach senior compliance specialists.
- Oversee compliance technology adoption and digital transformation.
- Align compliance operations with business performance and industry benchmarks.
- Represent the organization at external forums, industry events, and regulatory agencies.
- Lead post-merger, expansion, and business integration compliance due diligence.
QualificationsRequired Skills and Experience- Minimum 12 years of compliance, quality systems, or regulatory program experience, or equivalent combination of education and experience.
- Deep expertise in global or regional regulations and quality system requirements relevant to the business.
- Demonstrated experience leading enterprise or global compliance programs, major risk assessments, remediation projects, audit responses, investigations, and cross-functional initiatives.
- Mastery in strategic planning, policy writing, enterprise risk management, audit management, and regulatory interface activities.
- Strong executive communication, training, talent development, change leadership, and program management capabilities.
- Ability to influence senior leaders and represent the company in regulatory, client, or industry interactions.
Required Education and Training - Bachelor's degree in a relevant field, or equivalent combination of education and experience.
- Advanced degree preferred.
- Training or certification in quality systems, auditing, enterprise risk management, regulatory compliance, project management, change leadership, or compliance program management preferred.
Working Conditions - Office or hybrid work environment.
- Frequent interaction with executives, process owners, auditors, regulators, clients, industry representatives, and cross-functional teams.
- Work may involve high-priority compliance issues, regulatory inspections, major remediation programs, and complex implementation schedules.
- Requires the ability to support global teams, business needs, and time-sensitive compliance commitments across time zones.
- Domestic and international travel required.
Preferred Skills and Experience - Experience leading enterprise QMS programs, global compliance harmonization, regulatory remediation, Class II or Class III medical device compliance, IVD or IVDR, post-merger integration, digital compliance transformation, regulatory agency interactions, and executive governance forums.
- Advanced certifications such as ASQ CQA, CQE, CMQ/OE, RAC, Lean Six Sigma Black Belt, PMP, or enterprise risk management certification preferred.
- Experience influencing executive leadership and representing the company externally preferred.
Additional InformationDue to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.
This position may be filled at a different job level than listed here depending on
business need and/or on the selected candidate's experience, knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidate's qualifications, consistent with applicable law.
We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target compensation ranges are listed.
