Regulatory Affairs Specialist 4

Primary Function of Position

The Senior Regulatory Affairs Specialist serves as the primary point of contact for regulatory strategy and execution of projects involving complex electromechanical software controlled robotic systems instruments and accessories SaMD and advanced imaging systems. The Senior RA Specialist works across the organization and liaises with global regulatory counterparts on a wide range of products including capital equipment instruments and accessories (single use or re-usable) and software focusing on supporting ongoing changes and continuous improvement to these products.

Essential Job Duties

• Support product engineering and manufacturing teams on regulatory issues including review of design input risk management and test documentation
• Evaluate changes to products including changes to design material labeling packaging manufacturing process and facility
• Assess the impact of the product/process changes and determine regulatory pathway for US markets
• Present regulatory strategy and status in internal group settings
• Gather information from international counterparts for ROW regarding the impact of changes and work with international counterparts to coordinate global regulatory submissions/approvals
• Prepare internal documentation and prepare and submit regulatory filings including non-filing justifications (NFJ) and 510(k)s Provide oversight of third party agency testing (UL EMC biocompatibility sterilization) as required Perform other duties as required

Qualifications :

Required Skills and Experience

• Minimum of 8 years experience working in a medical device company performing regulatory submissions and technical documentation (can be in combination with a Masters in Regulatory Science or Master of Engineering
• Biomedical Engineering) Experience working with cross-functional teams including engineering manufacturing quality marketing clinical labeling packaging etc.
• Working understanding of FDA regulations
• Ability to work with cross functional project teams and understand complex products
• 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
• Ability to review and provide critical feedback on design documentation
• Strong interpersonal and project management skills

Required Education and Training

• Minimum B.S. or higher in Biomedical Engineering Electrical Engineering Mechanical Engineering or Pharmacy preferred.

Working Conditions

• Must wear personal protective equipment as defined/required by job assignments.
• Must be able to lift/carry 50lbs
• May be exposed to radiation or electromagnetic fields lasers noise > 80dB TWA allergens/biohazards/chemicals (cautery smoke)
• Subject to and expected to comply with all applicable Intuitive policies and procedures

Preferred Skills and Experience

• Previous regulatory submissions experience with complex electromechanical software controlled robotic systems SaMD or advanced imaging systems preferred.

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