Regulatory Policy & Standards Specialist
USA Personal services
Job description
**This is a remote-based position**
Siemens Healthineers is a leading global medical technology company with over 170 years of experience and 18,000 patents. More than 66,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. We stand with our customers around the world to support them in delivering high quality care to their patients. An estimated 5 million patients across the globe benefit every day 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. This is what truly matters to us.
Join our team now at Siemens Healthineers as a Regulatory Policy and Standards Specialist, remote-based to support the North America (NAM) Regulatory Policy and Standards program.
This is a role well suited to an ambitious professional, looking for the next step in their career. As a Regulatory Policy and Standards Specialist, you will be responsible for:
- You are responsible for providing support primarily on federal level regulatory policy and standards topics. The topics related to major medical-technology hub cities in the NAM region may be added to the scope of this position as needed. The activities include:
- Proactively track changes in regulatory policy and standards topics as relevant.
- Coordinate Siemens Healthineers participation in industry association activities (e.g. AdvaMed Imaging, AdvaMed, and MedTech Canada).
- Ensure that Siemens Healthineers position is articulated through appropriate channels to influence Regulatory and Standards Activities.
- You 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.
- You 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.
- This position formally reports directly to Siemens Healthineers Vice President, Quality and Technology – North America, but receives all instruction, guidance and responsibilities from the Head of Regulatory Policy for the United States and Canada who oversees the Regulatory Policy and Standards program for NAM.
This position may suit you best if you are familiar with what is below, and would like to develop your career with Healthineers:
- You proactively assist in the identification of and internal distribution of Regulatory and Standards topics that impact Siemens Healthineers in NAM region, and investigate and monitor time-sensitive Regulatory and Standards topics.
- You support collaboration with internal Regulatory and Standards subject matter experts to examine emerging key Regulatory and Standard policy issues under the direction of the Head of Regulatory Policy.
- You assist in soliciting and consolidating responses to achieve internal consensus on Regulatory and Standards topics affecting Siemens Healthineers operations.
- You facilitate the exchange of information with external industry trade associations and standards development organizations under the direction of the Head of Regulatory Policy.
- You communicate Siemens Healthineers position to external parties under the direction of the Head of Regulatory Policy.
- You attend as needed internal and external Regulatory and Standards meetings (e.g. AdvaMed Imaging, AdvaMed and MedTech Canada working group teleconferences); provide reports from those meetings in a timely manner to the Head of Regulatory Policy and relevant internal Siemens Healthineers subject matter experts.
- You provide reports as needed and in a timely manner on Regulatory and Standards activities. This includes assistance in generating periodic internal reports as well as providing reports (synopsis, outcomes, action items) from meetings, Federal/State/Province level events, and all affiliated trade organization teleconferences. This further includes an internal weekly collaboration meeting, periodic newsletter, and maintenance of internal NAM Regulatory Policy and Standards intranet site.
- You coordinate Siemens Healthineers participation in industry association activities (e.g. AdvaMed Imaging, 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.
- You handle external relations in a way that supports the work of and enhances the reputation of Siemens Healthineers.
- You establish and maintain relationships with internal parties (SMEs) and any affiliated Regulatory and Standards consortia.
- Regulatory Policy and Standards topics related to major medical-technology hub cities in NAM region may be added to the scope of this position as needed.
- Additional responsibilities may be added by the Head of Regulatory Policy as needed.
Required skills to have for the success of this role:
- 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 is 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.
At Siemens Healthineers, we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry. What unites and motivates our global team is the inspiration of our common purpose: To innovate for healthcare, building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services. We recognize that taking ownership of our work allows both us and the company to grow. We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally.
If you want to join us in transforming the way healthcare is delivered, visit our career site at https://usa.healthcare.siemens.com/careers
If you wish to find out more about the specific details before applying, please visit: https://usa.healthcare.siemens.com/about
As an equal-opportunity employer, we are happy to consider applications from individuals with disabilities.
*LI-WC1
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