Medical Device, Quality/Risk Management, US Regulatory Affairs
4 Year Degree
We are seeking a Regulatory Technical Specialist based in Malvern, PA to support the NAM Technical Regulations and Standards (TRS) program.
This position formally reports directly to Siemens Healthineers Vice President, Quality and Technology – North America, but receives all daily instruction, guidance and responsibilities from the Technical Regulations and Standards Director (TRSM) for the United States and Canada who oversees the TRS program for NAM.
The Regulatory Technical Specialist is responsible for providing support primarily on State/Province level TRS topics. TRS topics related to major medical-technology hub cities in the US may be added to the scope of this position as needed. The activities include:
Proactively track changes in TRS topics as relevant.
Coordinate Siemens Healthineers participation in industry association activities (e.g. MITA, AdvaMed, and MedTech Canada).
Ensure that Siemens Healthineers position is articulated through appropriate channels to influence Regulatory and Standards Activities.
This individual must be detailed and results oriented, capable of working in a fast-paced environment, prioritize commitments, and communicate well with others, both verbally and in writing.
This individual must be able to manage multiple projects; research, analyze and draft materials intended for both internal and external audiences; coordinate, execute and advocate Siemens Healthineers positions and priorities to influence regulatory and standards policies in the United States and Canadian markets.
Proactively assist in the identification of and internal distribution of State/Province level Regulatory and Standards topics that impact Siemens Healthineers NAM region.
Investigate and monitor time-sensitive State/Province level Regulatory and Standards topics.
Support collaboration with internal Regulatory and Standards subject matter experts to examine emerging key State/Province level Regulatory and Standard policy issues under the direction of the NAM Technical Regulations and Standards Director (TRSM).
Assist in soliciting and consolidating responses to achieve internal consensus on State/Province level Regulatory and Standards topics affecting Siemens Healthineers operations.
Facilitate the exchange of information with external industry trade associations and standards development organizations under the direction of the NAM Technical Regulations and Standards Director (TRSM).
Communicate Siemens Healthineers position to external parties under the direction of the NAM Technical Regulations and Standards Director (TRSM).
Attend as needed internal and external Regulatory and Standards meetings (e.g. MITA, AdvaMed and MedTech Canada working group teleconferences); provide reports from those meetings in a timely manner to the NAM Technical Regulations and Standards Director (TRSM) and relevant internal Siemens Healthineers subject matter experts.
Provide reports as needed and in a timely manner on State/Province level Regulatory and Standards activities. This includes assistance in generating periodic internal reports as well as providing reports (synopsis, outcomes, action items) from meetings, State/Province level events, and all affiliated trade organization teleconferences, meetings and events. This further includes an internal weekly collaboration meeting, periodic newsletter, and maintenance of internal NAM TRS intranet site.
Coordinate Siemens Healthineers participation in industry association activities (e.g. MITA, AdvaMed, and MedTech Canada) and in standards development organizations (e.g. AAMI). This includes representing Siemens Healthineers in such groups, ensuring SME participation when needed, and maintaining internal industry association rosters/SME distribution lists.
Handle external relations in a way that supports the work of and enhances the reputation of Siemens Healthineers.
Establish and maintain relationships with internal parties (SMEs) and any affiliated Regulatory and Standards consortia.
TRS topics related to major medical-technology hub cities in the US may be added to the scope of this position as needed.
Additional responsibilities may be added by the NAM Technical Regulations and Standards Director (TRSM) as needed.
Required Knowledge/Skills, Education, and Experience:
Candidate must have at least 3-5 years previous work experience in regulatory affairs and/or standards policy analysis. Prior work experiences at FDA or industry associations a plus.
BS/BA in related discipline, Public Health, Health Policy, Political Science, or other relevant background. MS preferred and advance degree may be substituted for experience where applicable.
Required travel – 20%
Excellent communication and interpersonal skills.
Ability to work independently and escalate complex, unexpected challenges to management. Identify and resolve problems and apply problem-solving skills in difficult situations.
Ability to collaborate both internally and externally.
Superior organizational and technical writing skills.
Ability to monitor multiple topics concurrently and shift focus to higher priority topics with ease.
Ability to manage internal and external communication, participation in external committees and working groups.
Outstanding oral, written, and presentation skills,
Ability to establish and maintain effective working relationships with others.
Internal Number: 187735
About Siemens Healthineers
At Siemens Healthineers USA, our purpose is to enable healthcare providers to increase value by empowering them on their journey towards expanding precision medicine, transforming care delivery, and improving patient experience, all enabled by digitalizing healthcare.
An estimated five million patients globally everyday benefit from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services.
We are a leading medical technology company with over 120 years of experience and 18,500 patents globally. With about 50,000 dedicated colleagues in over 70 countries, we will continue to innovate and shape the future of healthcare.