Regulatory Affairs Specialist 3

Primary Function of Position

Serve as the primary regulatory representative on project and product core teams. The specialist works across the organization in supporting design control activities, US and Canada regulatory assessment and submissions, and liaises with global regulatory counterparts on a wide range of products

Essential Job Duties

• Develop regulatory pathway for US FDA and Canada new product registration, support product development and manufacturing teams in providing regulatory input and oversight, including review of documentation and communicating applicable regulatory requirements.
• Assess the impact of the product and process changes, establish regulatory pathways for US and Canada markets, and prepare the corresponding regulatory submission or internal documentation.
• Author regulatory submissions for US FDA 510(k) premarket notifications, internal “Letters to File” and Health Canada registration, and drive the review process through clearance/approval, where applicable.
• Gather information from international counterparts regarding submission pathways and impact of changes and support international counterparts in global regulatory submissions/approvals.
• Create and maintain product summary technical file (STED)
• Identify and convey requirements from applicable standards and guidance documents to project teams.
• Provide leadership on documentation issues and mentor teams on requirements.
• Continuous improvement of the submission process in accordance with Intuitive Surgical Product Development Process.
• Work directly with regulatory agencies on regulatory issues and submissions.
• Support international regulatory activities upon request.
• Perform other duties as required

Required Skills and Experience

• Ability to work in a fast-paced environment and handle multiple projects simultaneously.
• Ability to author and manage US FDA and Canada submissions and review processes.
• Understanding of design controls with experience in verification and validation methods and documentation and their relevancy to regulatory assessments
• Ability to quickly learn third-party test requirements such as UL / IEC product testing, biocompatibility, sterilization, etc.
• Exceptional verbal and written communication skills, proven ability to translate technical documentation into effective regulatory submissions.
• Ability to digest and convey information to project teams from regulators including regulations, guidance documents, and standards.
• Ability to review and provide critical feedback on design documentation.
• Ability to learn internal procedures and processes and implement on project teams.
• Good interpersonal skills and ability to work well with cross-functional teams.
• Good project management skills.

Required Education and Training

• Minimum 5 years relevant experience working in a medical device company (can be in combination with a regulatory degree, e.g., Masters in Regulatory Science)

Preferred Skills and Experience

• Experience with software-controlled and/or software in medical devices including cybersecurity is a plus.
• RAPS - RAC Certification is a plus

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.

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.

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 / Affirmative Action 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.

EEO and AA Policy

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.