Senior Regulatory Affairs Specialist

Primary Function of Position

The Sr. Regulatory Affairs serve as the primary regulatory representative on product and project teams supporting product lifecycle management activities. Responsibilities include developing regulatory plans reviewing design input/output documentation identification of applicable standards and guidance documents performing regulatory assessments to determine the impact of design/process changes preparing regulatory submissions maintaining regulatory filings and licenses and interacting with regulatory agencies

Essential Job Duties

• Serve as the global regulatory liaison and primary point of contact for product and project teams.
• Provide regulatory guidance to product teams develop regulatory plans and review and approve product design control documentation.
• Determine regulatory pathways and formulate regulatory strategies for the U.S. and Canadian markets. Assess regulatory impact on design materials labeling packaging manufacturing processes and facility changes. Influence and lead global regulatory strategies.
• Author and lead regulatory documentation and submissions including U.S. FDA 510(k) premarket notifications internal Letters to File pre-submissions with minimal supervision.
• Coordinate with technical experts to provide additional data/information requested by regulatory agencies and prepare responses to facilitate regulatory approvals.
• Provide risk-based guidance and regulatory input to projects and issues ensuring cross-functional alignment and resolution.
• Collaborate with international counterparts to support global regulatory submissions approvals and implementation rollouts.

Qualifications :

Required Skills and Experience

• Minimum 8 years of regulatory affairs experience working in a medical device company (can be in combination with a regulatory affairs master degree; e.g. Masters in Regulatory Science)
• In-depth understanding of US Medical Device regulations and EU MDR especially as it related to Digital and SW related projects.  
• Regulatory working knowledge of product lifecycle management design controls risk management verification and validation and product labeling requirement
• Ability to work in a fast-paced environment and handle multiple projects simultaneously
• Strong verbal and written communication skills proven ability to translate technical documentation into effective internal documentation and regulatory submissions
• Team player who seeks to help and learn from colleagues seeing the department success as their own
• Strong interpersonal and negotiation/influencing skills while maintaining a high level of professionalism
• Proactively seeks to develop and become well-versed within the regulatory landscape.

Required Education and Training

• Minimum B.S. or higher in Biomedical Engineering Electrical Engineering Mechanical Engineering or Pharmacy preferred. Non-technical degrees with equivalent complex medical device experience are acceptable.

Preferred Skills and Experience

• RAPS Regulatory Affairs Certification (RAC) is a plus.

Additional Information :

Due 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.

Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees and prohibit discrimination and harassment of any type without regard to race sex pregnancy sexual orientation gender identity national origin color age religion protected veteran or disability status genetic information or any other status protected under federal state or local applicable laws.

Mandatory Notices

U.S. Export Controls Disclaimer:  In accordance with the U.S. Export Administration Regulations (15 CFR 743.13(b)) some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employeeswho are nationals from countries currently on embargo or sanctions status.

Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the governments licensing process can take 3 to 6 months) or (ii) implement a Technology Control Plan (TCP) (note: typically adds 2 weeks to the hiring process).  

For any Intuitive role subject to export controls final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employeesstart date which may or may not be flexible and within a timeframe that does not unreasonably impede the hiring need. If applicable candidates will be notified and instructed on any requirements for these purposes. 

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Preference will be given to qualified candidates who do not reside or plan to reside in Alabama Arkansas Delaware Florida Indiana Iowa Louisiana Maryland Mississippi Missouri Oklahoma Pennsylvania South Carolina or Tennessee.

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.

Remote Work :

No

Employment Type :

Full-time