The Regulatory Affairs Technical Specialist (RA Specialist) position is a U.S. regulatory affairs specialist role that supports the imaging business units (BU), based outside of the U.S. (Germany/China) by guiding the writing and filing of the appropriate FDA pre-market medical device submissions (510(k) and PMA) to ensure that the devices are commercially available in the U.S; ensuring that products and product modifications introduced into the U.S. price-book fall within the scope of their U.S. clearance and guides the review of promotional material and device labeling for regulatory compliance.
The RA Specialist will act as the subject matter expert and coordinate regulatory projects, project schedules, and the product introduction process in the U.S; participate in the decision making process on regulatory submission issues using historical knowledge and FDA's current regulations regarding the medical device industry; train the BU counterpart(s) in Germany & China on FDA requirements and act as the liaison with FDA and the manufacturing facility.
In this position, the RA Specialist will report to RA/CA management in the U.S. and work closely with the fellow RA/CA Specialists, BU Regulatory and Manufacturing, and BU & U.S. Marketing teams, to help align the regulatory submissions objectives. This includes interfacing with multiple functional areas, geographies and divisions.
Ensure that the products are commercially available and in line with U.S. business goals.
Perform the preparation, writing and filing of appropriate FDA pre-market submission to ensure that the devices and their messaging are commercially available in the U.S. (510(k)s, PMAs, etc.)
Coordinate FDA pre-IDE/pre-Submission Meetings & the development of IDEs.
Coordinate the preparation of additional data/information requested by regulatory agencies and prepare appropriate responses to all such requests & take the lead in regulatory agency. negotiations and face-to-face meetings.
Act as the liaison with FDA and BU manufacturing facility.
Interact with the U.S. marketing team to identify promotion requirements for the U.S. market.
Coordinate the development and documentation of decisions not to seek FDA clearance/approval for device modifications.
Control the introduction of product to the United States market through the Regulatory Review and Approval of new and modified product introduction.
Review external communication material and device labeling, including quote text, for regulatory compliance.
Represent Siemens in Industry Organizations (e.g., MITA)
Train HC QT NAM USA staff and factory based staff to ensure an appropriate understanding of applicable regulations and procedures.
Maintain regulatory files according to regulations and company records retention policies and acts as central point of contact as needed and maintain records/databases/logs as required to provide metrics to management.
Assists the HC QT NAM USA Regulatory, Quality and Clinical Affairs Department in ensuring its responsibility for the QSR compliance of the HC NAM USA organization.
Provide metric and KPI data as requested by management.
Assist with the Regulatory Affairs budget and operates within that budget.
Provide specialized guidance, or train support and/or professional staff, including the RACA team
Required Knowledge/Skills, Education, and Experience
Minimum 5 - 8 years’ experience in regulatory affairs (510(k), PMA, QSR) and successful demonstration of Key Responsibilities and Knowledge as presented above or equivalent education, technical knowledge with Medical Devices or Imaging Products may suffice.
Strong written and oral communication, and technical writing and editing skills.
Ability to manage and prioritize multiple projects with strong attention to details
Ability to understand technical topics and regulatory science Travel: 10-20% (Domestic and International)
Preferred Knowledge/Skills, Education, and Experience
Demonstrated performance in advanced areas of work in the regulatory field.
Independently apply skills to successfully identify and resolve moderately complex problems not covered by existing procedures or practices.
Successfully apply complex knowledge of fundamental concepts, practices, and procedures of particular area of specialization.
Demonstrates knowledge of organization's business practices and issues.
Ability to display a high level of critical thinking in bringing successful resolution to high-impact, complex, and/or cross-functional problems.
Internal Number: 233475
About Siemens Healthineers
Siemens’ Healthcare Sector is one of the world's largest suppliers to the healthcare industry and a leader in medical imaging, laboratory diagnostics, medical information technology and hearing aids. Siemens Healthcare offers its customers products and solutions for the entire lifecycle of patient care – from prevention and early detection, to diagnosis, treatment and aftercare. By optimizing clinical workflows for the most common diseases, Siemens also makes healthcare faster, better and more cost-effective. Siemens Healthcare employs over 50,000 employees worldwide. In fiscal year 2011, the Healthcare Sector posted revenue of 12.5 billion Euros. For more information on the Healthcare sector, visit: www.siemens.com/healthcare.