What are the responsibilities and job description for the Sr. Regulatory Affairs Specialist position at Intuitive?
Company Description
Job Description
Primary Function of Position:
The Regulatory Operations Specialist / Engineer serves as the primary regulatory lead on projects involving highly innovative, unique, cutting edge, complex and diverse products used in the minimally invasive robotically assisted surgery space. The Specialist/Engineer works across the organization and liaises with global regulatory counterparts on a wide range of products – over 400 SKUs including capital equipment, instruments and accessories (single use or re-usable), and software, focusing on supporting ongoing changes and continuous improvement across the board to these products.
Roles & Responsibilities:
- 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 and EU markets
- 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 for the above markets including Non-filling justifications, 510(k)s, and Technical File updates
- Work with Notified Body to obtain approval for changes to products
- Provide oversight of third party agency testing (UL, EMC, biocompatibility, sterilization Assurance) as required
- Perform other duties as required
Qualifications
Skills, Experience, Education, & Training:
- Minimum B.S. or higher in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or Pharmacy preferred.
- Non-technical degree with equivalent complex medical device experience acceptable 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.
- Skills:
- In-depth understanding of FDA and CE mark 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
- Ability to learn internal procedures and processes and implement the same on project teams
- Good interpersonal skills and project management skills
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.