Intuitive Surgical Careers
RA/QA Manager - APAC LACA Direct Markets
Primary Location: United States-California-US-CA-Sunnyvale
Requisition ID: 182952
Who is Intuitive Surgical? The numbers tell an amazing story. Learn more about our company.
Joining Intuitive Surgical means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and decreasing surgical invasiveness, with patient safety as our highest priority.
Primary Function of Position:
Manage, develop, organize and support the implementation of the proper RAQA requirements related to QA / QMS and regulatory submissions for direct APAC and Latin American regions in coordination with global teams as well as local or regional teams.
Interpret regulatory rules and quality system requirements and ensure that they are communicated through corporate policies and procedures. Create awareness within the organization regarding the international and domestic regulations and the product specific standards. Develop and implement departmental regulatory processes. Understand quality system requirements in each region and determine how we integrate these in the design process and support accordingly those countries or regions.
Develop a RAQA culture and mindset.
Roles & Responsibilities:
• Provide RAQA leadership to develop a high performing & engaged team in the responsible region(s), Asia Pacific and/or Latin America
• Establishes & supports team members in consistently achieving their targets, goals and objectives.
• Work with cross-functional teams to represent the region(s)
• Work with team to create and review DOPs and WIs
• Maintain knowledge of regulatory affairs guidelines of Asia Pacific countries and/or Latin America countries
• Compile and maintain regulatory documentation database and system.
• Coordinate, prepare regulatory filings of summary technical documents and work with in-country regulatory personnel to submit it to regulatory authorities in Asia Pacific and/or Latin America region(s)
• Prepare and submit notifications to in-country regulatory personnel for new products and changes to existing products in Asia Pacific and/or Latin America region(s)
• Support product development teams with regards to implementation of regulatory requirements
• Help determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes
• Maintain regulatory clearances and approvals with necessary filings and communications
• Continuous improvement of the processes
• Work directly with regulatory agencies on regulatory issues and submissions as required
• Communicate changes related to registration licensing and collect information on registration instructions and regulations
• Perform other duties as required
• B.S./B.E. or higher in Engineering, Biomedical Engineering, Regulatory or quality degree or Mechanical Engineering or related field.
• 7+ years of regulatory and quality experience with 5+ years of experience in submissions and technical documentation for a medical device company.
• Minimum 2 years of experience managing a team in different regions OUS.
• International RAQA experience is desired but not required.
• Experience working directly with the FDA, Notified Bodies, and other regulatory agencies, including leading and/or supporting audits.
• Overall understanding of US and CE Mark regulations, Quality System requirements, Design Control, verification and validation methods, risk management, labeling etc.
• Track record of building high performing teams or mentoring skills.
• RAC (regulatory affairs certified) desirable as well as lead auditor skills.
• Strong verbal and written communication skills, proven ability to translate technical documentation into effective regulatory submissions.
• Good interpersonal skills and able to work well with cross-functional teams.
• Good project management and critical thinking skills
We are an AA/EEO/Veterans/Disabled employer.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.