Senior Regulatory Affairs Specialist

Job Description

Primary Function of Position
The Sr. Regulatory Affairs Specialist’s primary 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.
 

Essential Job Duties

• 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, Health Canada 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, Health Canada guidance and EU MDR.
• 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 employees
who 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 government’s 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 employee’s
start 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.

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.