Sr Regulatory Affairs Specialist

Company Description

At 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 Sr Regulatory Affairs Specialist is responsible for providing strategic guidance regarding the establishment and implementation of the regulatory clearance strategy, and ensuring digital medical device regulatory clearance to enable market access by demonstrating compliance to applicable regulations through a registration dossier.

Roles & Responsibilities:

• Core team RA functional lead acted as liaison between cross-functional team and international counterparts for ROW regarding the impact of changes and work with international counterparts to coordinate global regulatory submissions/approvals, and implementation roll-out
• Develop and recommend strategies for new product development and changes to products including changes to design, technology or labeling.
• Providing regulatory guidance and direction, inclusive of potential risks, to cross-functional business partners and company leadership. Creatively identifies risk-based solutions and strategies for problem solving
• Perform other duties as required
• Assess the impact of the product/process changes and determine regulatory pathway for US and EU markets
• Provide risk-based guidance and strategic input into projects and issues and help facilitate cross functional alignment and resolution
• Lead, plan, coordinate, and prepare US regulatory submissions of various types, including US FDA 510(k) premarket notifications, and internal “Letters to File”, as applicable.
• Support product engineering and manufacturing teams on regulatory issues, including review of design input, risk management and test documentation
• Provides technical guidance and regulatory training/mentoring to other RA employees and cross-functional teams

Qualifications

Required Knowledge, Skills and Experience

• RAPS Regulatory Affairs Certification (RAC) is a plus
• Team player who seeks to help and learn from colleagues seeing the department success as their own
• Strong verbal and written communication skills, proven ability to translate technical documentation into effective internal documentation, and regulatory submissions
• Proactively seeks to develop and become well-versed within the regulatory landscape.
• Full time position, Sunnyvale ,CA location required
• Extensive working knowledge of design controls, risk management, verification and validation, and product labeling requirements/documentation
• Knowledge of non-medical device regulations (eg FCC, CE Marking, …) is a plus
• Experience with complex products including Software as a Medical Device is a plus
• Education: Minimum B.S. or minimum higher in Computer Sciences, Biomedical Engineering, or Pharmacy preferred. Non-technical degree with equivalent complex medical device experience acceptable
• Strong interpersonal and negotiation/influencing skills while maintaining a high level of professionalism
• Ability to work in a fast-paced environment and handle multiple projects simultaneously
• Experience: Minimum 8 years of experience in Medical Device industry with roles showing increasing responsibility and 5+ years of medical device regulatory affairs experience in US and submissions and EU technical documentation with solid knowledge of medical device regulations in regard to end-to-end product lifecycle management
• In-depth understanding of US and EU Medical Device regulations
• Race, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

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 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:$126,500 - $182,100
Base Salary Range Region 2: $107,600 - $154,800
Shift: Day
Travel: None