This position will determine the current regulatory requirements and strategies for Terumo’s devices and projects and define information and actions necessary to meet requirements. Determining strategy and requirements within the position will vary in complexity based on scope and different regulatory markets. This position will prepare documents and/or submissions required to obtain clearance or approval from government agencies for commercial distribution of products worldwide. Serves as a liaison between Regulatory Agencies and Terumo Medical Corporation. Mistakes made in this area can be very costly, i.e., delays in product clearance or approval withdrawal of product from the marketplace, or enforcement of fines. Any of the above would have a major impact on the corporation.
Associate is responsible to follow requirements of applicable national and international regulations.
Analyze data received and prepare documentation for complex submission which may contain clinical trial data for the purpose of obtaining clearance and or approval for product distribution.
Participates on product design teams and verifies compliance with design control requirements and procedures.
Determine appropriate regulatory requirements and strategies for new product development 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 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, Canadian, MDR and International regulations pertaining to legal distribution of medical products.
Stays abreast of Regulatory Agency 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 International product registrations as well as certification of appropriate US commercialization status.
Have a proactive contribution approach to the overall Regulatory Affairs Department growth.
Participate in project performance team meetings on behalf of the business unit to provide ideas, methods, or processes for unit/company performance improvement.
Develop global regulatory strategies for high risk products and lead multidisciplinary project teams.
Provide general regulatory consultation during absence of other associates and/or manager
Performs other job-related duties as assigned.
Knowledge, Skills and Abilities (KSAs)
Demonstrate the ability to complete regulatory submissions independently
Advanced ability for independent work, teamwork, and decision making
Strong demonstrated ability for decision making based on interpretations of federal laws, which in many instances are very general in nature
Strong ability to develop global regulatory strategies for high risk products and lead multidisciplinary project teams
Ability to lead and mentor Regulatory Affairs associates.
Knowledge of FDA, Canada, EU, MHLW, TGA and other International requirements.
Knowledge of product labeling requirements and standards.
Requires a minimum of a 4-year degree in engineering, life sciences, or similar discipline
Master’s Degree in Regulatory Affairs, Life Sciences or Engineering preferred.
Requires a minimum of ten years of relevant experience of increasing responsibility, or combination of equivalent education, background, and experience.
Experience in a medical device quality assurance environment preferred
Regulatory Affairs Certification preferred.
Experience with 510(k)/IDE/PMA device submissions and/or other worldwide submissions and clearances required.
- Clinical Trials
- Data Analysis
- Decision Making
- Federal Laws