Regulatory Affairs Specialist - Latin America/APAC
March 6, 2018
Full Time - Experienced
Latin America/Caribbean Regulatory Affairs, Medical Device, Quality/Risk Management, Submission & Registration
4 Year Degree
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:
Coordinate, prepare, or review regulatory submissions for Asia Pacific and Latin America projects. The primary focus will be Latin America countries for this position. Interpret regulatory rules or rule changes 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. Additional responsibilities include maintaining regulatory filings and licenses.
Roles and Responsibilities:
Maintain knowledge of regulatory affairs guidelines of Korea, Japan, China, Taiwan and other Asia Pacific countries (APAC) and 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 Latin America regions
Collect supporting documents for submissions in APAC and Latin America regions
Create/order/legalize CFGs to support submissions
Provide feedback and recommendations to cross-functional team regarding new product plans
Assess changes and prepare/submit notifications to in-country regulatory personnel for new products and changes to existing products in Asia Pacific region and Latin America regions
Support product development team and other departments with regards to implementation of regulatory requirements to assure compliance
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
Create RAO/MCOs/ECOs as needed
Continuous improvement of the submission process
Update registration licensing and collect information on registration instructions and regulations
Assist with recall or market withdrawal activities as necessary
Update Regulatory SAP list
Perform other duties as required
B.S./B.E. or higher in Biomedical Engineering, Electrical Engineering or Mechanical Engineering preferred
Medical device RA experience is required.
International RA experience is required.
Non-technical degree with equivalent complex medical device experience acceptable
RAC (regulatory affairs certified) desirable
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
Self-motivated and self-starter
Good project management skills
Critical thinking skills
Ability to speak and write in Spanish is a plus.
Experience: • 4-6 years relevant experience working in a medical device company. • 2 + years of experience in submissions and technical documentation for APAC and/or Latin America countries at a medical device company. • Experience with new product development projects for complex products. • Experience with both capital equipment and disposable devices • Experience in verification and validation methods and documentation.
Training at Intuitive (on the job): • Agile: Be able to create, review, and approve ECOs. Facile in using Agile search capability to research change history on documents, parts and assemblies.
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.
Internal Number: 180311
About Intuitive Surgical
Surgical robotics was little more than a medical curiosity until 1999, the year Intuitive Surgical introduced the da Vinci® Surgical System. Today, Intuitive Surgical is the global leader in the rapidly emerging field of robotic-assisted minimally invasive surgery. Since its inception, the company has consistently provided surgeons and hospitals with the tools needed to improve clinical outcomes and to help patients return to active and productive lives.
With its corporate headquarters located in Sunnyvale, California, Intuitive Surgical serves customers throughout the United States and internationally, providing technology and procedural innovation across cardiac, urology, gynecologic, pediatric and general surgical disciplines.