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In an environment where medical product regulations seem to be expanding continuously, proportional investment in compliance infrastructure and controls runs the risk of diminishing returns. The key to achieving the right balance of commercial success and compliance is to focus on continuous improvement, specifically root-cause analysis.
The US Food and Drug Administration (FDA) has published a new draft guidance intended to assist industry with developing products under the agency's so-called "Animal Rule," a regulatory pathway intended to facilitate approvals of medical countermeasures to rare, emerging or serious pathogens.
Medical Device, Quality/Risk Management, Submission & Registration, US Regulatory Affairs
4 Year Degree
Sr. Reg Affairs Specialist (or) Principal Reg Affairs Specialist
Based in Elkton, MD (open to Somerset, NJ Applicants)
Determine current regulatory requirements and strategies for Terumo Medical Corporation and Terumo Corporation projects. Defines information and actions necessary to meet these requirements. Prepares documents and or submissions required to obtain clearance or approval from government agencies for commercial distribution of products worldwide. Serves as a liaison between the FDA 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 market place, 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 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 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 guidances.
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.
Must make a proactive contribution to the overall Regulatory affairs department growth.
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.
Provide general regulatory consultation during absence of other associates and/or manager
Performs other job related duties as assigned.
Demonstrate the ability to complete internal update preparations independently and completion of at least five (5) during TMC employment (or equivalent at prior employment).
Advanced ability for independent work, team work, and decision making
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.
Able to lead and mentor RA associates regardless of location.
Typically requires a 4 year degree in life sciences.
Regulatory Affairs Certification preferred.
Minimum 7 years experience in Regulatory Affairs or a Master in Regulatory Affairs and 5 years experience.
Pre-sub, IDE and/or PMA submission experience.
Must have completed three (3) 510(k) submissions and demonstrated ability to prepare submissions independently.
Management experience (project or supervisory management)
Demonstrated the ability to develop global regulatory strategies for high risk products and lead multidisciplinary project teams
Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved qu...ality of life for patients. TMC is part of Tokyo-based Terumo Corporation; one of the world’s leading medical device manufacturers with almost $5 billion in sales and operations in more than 160 nations. Terumo Medical Corporation is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products