Head of Regulatory Policy – North America
Business Unit: Quality & Technology
Requisition Number: 232900
Primary Location: United States-Pennsylvania-Malvern
Assignment Category: Full-time regular
Experience Level: Senior level
Education Required Level: Bachelor's Degree
Travel Required: 20%
· Reports directly to Siemens Healthineers Vice President, Quality and Technology – North America (United States and Canada).
· Responsible for North America regulatory and standards policy initiatives and activities. This key role is responsible for assessing, integrating, shaping, maintaining and advocating Siemens Healthineer’s regulatory and standards policy positions.
· In this role, the Head of Regulatory Policy will work collaboratively to build and maintain relationships with key regulatory authorities, standards development organizations and industry associations; assess the current regulatory and standards environment; anticipate regulatory and standards trends; and develop/maintain a deep understanding of guidances, regulations, laws and standards that impact Siemens Healthineers product portfolio and business objectives.
· Serve as appointed Technical Regulations and Standards Manager (TRSM) for the United States and Canada. Acts as the lead and subject matter expert for all related aspects of Technical Regulations and Standards (TRS) in the United States and Canada.
· Serve as appointed Technical Regulations and Standards Manager (TRSM) for the United States and Canada. As such fulfill the duties required by management and defined in the TRSM Guidance (GD35) and has the duty to effectively support the business by helping to shape future technical regulations and standards and ensure compliance with the appropriate regulations and standards. The TRSM acts as the primary contact for all related aspects of TRS in the United States and Canada.
· Advise senior management of FDA and Health Canada requirements and standards related to device development. Develop and maintain strong relationships with FDA and Health Canada.
· Collaborate and lead internal development of Siemens Healthineers responses to FDA, Health Canada, other government agencies, standards development organizations, etc. on regulations, guidance, legislative initiatives and standards topics of interest to Healthineers. Develop independently or solicit internal SME feedback, identify a unified position, communicate position externally, follow through, and report on outcomes.
· Represent Siemens Healthineers within industry associations (e.g., MITA, AdvaMed, DITTA, GMTA, Health Canada) on product and regulatory policy matters. Participate in, secure and hold key leadership positions in industry working groups to foster relationships and build advocacy strategies that enhance Siemens Healthineers and industry objectives.
· Manage Siemens Healthineers participation in industry/standards development associations (e.g., MITA/NEMA, AAMI) by serving as Healthineers primary representative in multiple industry working groups, acting as an advocate for Healthineers, and ensuring SME feedback relayed.
· Proactively monitor emerging regulatory policy and scientific trends/issues/topics for designated business lines/business areas – this includes topics with FDA, Health Canada, Federal or State/Provincial governments, industry consortia, other regulatory/governmental agencies, within the medical device industry or elsewhere and identify, assess and communicate those topics likely to impact Siemens Healthineers product portfolio. Serve as SME responsible for providing impact assessments of United States, Canada, and international regulations and standards which impact the medical device industry.
· Perform time-sensitive analysis, draft revisions and amendments to relevant regulations, standards, and legislative documents.
· Work cross-functionally with other Siemens Healthineers departments such as Global Policy and Strategy, Government Affairs, Legal, Marketing, etc. to align Healthineers position on key legislative, regulatory and standards topics.
· Represent Siemens Healthineers and industry groups in meetings with Federal, State/Provincial or Government Agency Officials (e.g., United States Congress, FDA/Health Canada, United States Department of Commerce, etc.).
· Prepare briefing materials, presentations, research and other materials for executive management, colleagues, and industry meetings.
· Provide regular reports of regulatory and standards activities to global network of over 200 colleagues – including internal meetings, FDA/Health Canada related events, relevant trade associations meetings (e.g., AdvaMed, MITA, DITTA, GMTA, MEDEC), and industry consortia (e.g., MDIC). Maintain TRS intranet page to apprise company personnel of United States, Canada and international trade, regulatory and standards activity.
· Attend and present at various internal meetings – Siemens Healthineers Quality conferences, Legal monthly calls, TRS Council meetings, RA Imaging and Diagnostic meetings, etc. to advance internal knowledge and information sharing on key topics.
· Manage TRS staff (Regulatory Technical Specialist) by oversight and assignment of daily activities to support TRS activity.
Required Education, Qualifications and Skills:
· A Juris Doctorate or advanced degree preferred in science, public health, health policy, or law.
· Excellent communication and leadership skills. Ability to establish network and working relationships within Siemens (Healthineers and Siemens AG). Ability to establish external relationships with industry groups (e.g., MITA, AdvaMed, DITTA, GMTA, MEDEC, AAMI) and regulatory authorities (e.g., FDA, Health Canada).
· Excellent collaboration skills and ability to work in a team environment and individually.
· Experience and track record of effective collaboration within industry associations groups and/or with regulatory authorities via international forums (e.g., IMDRF).
· Ability to manage/lead internal and external topic focus groups, task forces, committees and working groups. Ability to manage internal TRS staff.
· Proven ability to react quickly to topics facing the industry in which Siemens Healthineers operates. Demonstration of strategic and proactive thinking as well as ability to manage numerous topics concurrently. Strength in prioritizing and anticipating emerging issues.
· Knowledge of current FDA and Health Canada requirements and industry standards, particularly in the device product regulatory area. Experience acting as a credible, reliable, influential and respected spokesperson on behalf of Siemens Healthineers and/or industry association groups during interactions with regulatory authorities to ensure appropriate, proactive communication with agency officials on key topics.
· Demonstrates knowledge of organization’s structure, business practices and topics of interest.
· Superior organizational, presentation, oral and technical writing skills. Proven ability to effectively and persuasively communicate complex topics at the highest levels of business and government.