Regulatory Affairs Professional
Regulatory Affairs (RA) Professional role supports the Siemens Healthineers
imaging business lines (BL) based outside of the U.S. (Germany/China) by
analyzing the requirements and preparation of product related pre-market U.S.
medical device submissions to the FDA (e.g. – pre-submission meetings, 510(k)s,
PMAs, PMA Annual Reports, PMA Supplements, etc.) and performs submission
related activities including: regulatory strategy, non-filing documentation,
review of products for commercial introduction into the U.S. market, review of
external communication material (Ad & Pro) for the U.S. market, etc.
Acts as the U.S. RA subject matter expert and coordinates regulatory projects, project schedules and the product introduction process in the U.S; participates in the decision making process on regulatory submission issues; trains BL counterpart(s) in Germany & China on FDA requirements and act as the liaison with FDA and the manufacturing sites.
Reports to SHS AM NAM QT RACA management in the U.S. and works closely with the fellow RA/CA team members, BL RA and Manufacturing teams, and BL/U.S. Marketing teams to help align the regulatory submissions’ objectives and meet business goals. This includes interfacing with multiple functional areas, geographies and divisions and collecting and reporting on KPI metrics.
- Identifies, analyzes and implements U.S. country specific requirements necessary for product related medical device FDA submissions
- Plans and prepares product related premarket medical device submissions with Siemens internal or external organizations according to regulatory requirements
- Performs regulatory projects or acts as a member of the project steering group
- Submits required documentation/information to U.S. authorities (FDA) or Siemens internal organizations
- Acts as Siemens’ interface and leader in all interactions with FDA (e.g. meetings, teleconferences and in writing)
- Initiates and escalates necessary activities if deviations are identified
- Performs review of promotional material and products being introduced into the U.S. market for regulatory compliance according to country specific (U.S.) requirements
- Performs training within the organization in country specific (U.S.) regulatory requirements
- Represent the company in industry associations (e.g. – MITA, ADVAMED, etc.)
- Creates quality guidelines and work instructions relevant for maintaining regulatory compliance
- Ensures creation of adequate documentation for audits/inspections
- Acts as a leader in the NAM QT RA/CA organization and assists with management responsibilities
Using professional expertise, with extensive functional, commercial and/or technical knowledge in regulatory affairs:
- integrates analysis, development, testing and implementation; interpret and functionally influence policy and guidelines in the U.S. regulatory environment
- develops processes and systems to deliver functional objectives
- plans own work according to targets agreed, within a quarterly & up to an annual cycle, by integrating resources in a project driven environment
- provides functional advice and guidance to colleagues and customers
- possesses a chartered professional qualification (e.g. RAC, etc.) or equivalent, (is typical, though not necessary)
Deep professional know-how and experience U.S. Regulatory Affairs. Transfers and applies “know-how” to/in various contexts. Solid professional judgment and problem solving competence. Improves existing processes and approaches.
Provide specialized guidance or train support and/or professional staff. Leadership qualities and role model qualities.
Is expected to adopt existing concepts, methodologies, etc. in order to create and open up new ways of approaching and fulfilling specific internal and external client requests or project requirements.
8-10 years’ experience in regulatory affairs (510(k), PMA, QSR) and successful demonstration of Key Responsibilities, Knowledge, Influence & Impact as presented above or equivalent education, technical knowledge with Medical Devices or Imaging Products may suffice.
Organization: Siemens Healthineers
Company: Siemens Medical Solutions USA, Inc.
Experience Level: Experienced Professional
Job Type: Full-time
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