Company DescriptionAt Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.
As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.
Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.
Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.
Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.
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 Sr. 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
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, regulatory, 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.
Preferred Skills and Experience
Previous regulatory submissions experience with complex electromechanical, software controlled robotic systems, SaMD or advanced imaging systems
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 Employment 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.
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 salary ranges are listed.
Base Salary Range Region 1: $132,000 USD - $190,000 USD
Base Salary Range Region 2: $112,300 USD - $161,500 USD
Travel: 10% of the time
Workplace Type: Set Schedule - This job will be onsite weekly, the percentage of onsite work will be defined by the leader.