Job Summary
Leads team to determine regulatory requirements and strategies for Terumo Medical Corporation and Terumo Corporation projects. Team will define information and actions necessary to meet these requirements. Oversees and assists in the preparation of documents and or submissions required to obtain clearance or approval from government agencies for commercial distribution of products worldwide. Serves as liaison between government agencies and Terumo. Mistakes made in this area can be very costly, i.e., delays in product clearance or approval withdrawal of product from the market place, or enforcement of fines. Any of the above would have a major impact on the corporation.
Job Details/Responsibilities
- Associate is responsible to follow requirements of applicable national and international regulations. Associate assists other Regulatory Associates in understanding how to interpret these regulations.
- Guides team in analyzing data received and preparing documentation for submission for the purpose of obtaining clearance and or approval for product.
- Participates on product design teams and verifies compliance with design control requirements and procedures.
- Determine appropriate regulatory requirements and strategies for TMC, TPC, TMPH, and TC projects including both domestic and foreign activities and provide regulatory consultation to other internal and external entities.
- Acquire and maintain a current knowledge of federal (US, Canadian, and Europe) regulations pertaining to the lawful distribution of products which include facility registration, device listing, labeling and promotional review.
- Maintain documentation and a historical record for projects and provide management with updated product status.
- Participate in task force groups and industry working groups.
- Maintains current knowledge of Federal USA and Canadian regulations pertaining to legal distribution of medical products.
- Stays abreast of FDA updates including new policies and guidance.
- Interact with production division, federal agencies, industry organizations, interdepartmentally and external departments at all levels.
- Assists external customers by supplying materials and documentation for US and foreign product registrations as well as certification of appropriate US commercialization status.
- Makes a proactive contribution to the overall Regulatory affairs department growth.
- Provides general regulatory consultation during absence of other associates.
- Participates in project performance team meetings on behalf of the business unit in order to provide ideas, methods or processes for unit/company performance improvement.
- Develop global regulatory strategies for high risk products and lead multidisciplinary project teams
- Performs other job related duties as assigned.
Knowledge, Skills and Abilities (KSA)
- Experience on Design Control project teams.
- Advanced ability for independent work, team work, and decision making
- Able to lead and mentor RA associates regardless of location
- Demonstrated the ability to make correct decisions based on interpretations of federal laws, which in many instances are very general in nature to accommodate a variety of industries. These interpretations are used for every aspect of the regulatory discipline from submissions to labeling issues.
- Demonstrated the ability to develop global regulatory strategies for high risk products and lead multidisciplinary project teams
- Requires ability to complete internal update (letters to file) preparations independently and completion of at least five (5) during TMC employment (or equivalent at prior employment).
Qualifications/ Background Experiences
- Typically requires a 4 year degree in life sciences
- 7 years of experience in Regulatory Affairs or a Masters in Regulatory Affairs and 5 years of experience.
- Regulatory Affairs Certification preferred.
- Pre-sub, IDE and/or PMA submission experience preferred.
- Must have completed three (3) 510(k) submissions and demonstrated ability to prepare submissions independently.
- Management experience (at least 2 years of project or supervisory management)
