Siemens Regulatory Affairs Professional in Malvern, Pennsylvania
Regulatory Affairs Professional
The 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 andimplements U.S. country specific requirements necessary for productrelated medical device FDA submissions
Plans and prepares productrelated premarket medical device submissions with Siemens internal orexternal organizations according to regulatory requirements
Performs regulatory projects oracts as a member of the project steering group
Submits requireddocumentation/information to U.S. authorities (FDA) or Siemens internalorganizations
Acts as Siemens’ interface andleader in all interactions with FDA (e.g. meetings, teleconferences and inwriting)
Initiates and escalatesnecessary activities if deviations are identified
Performs review of promotionalmaterial and products being introduced into the U.S. market for regulatorycompliance according to country specific (U.S.) requirements
Performs training within theorganization in country specific (U.S.) regulatory requirements
Represent the company inindustry associations (e.g. – MITA, ADVAMED, etc.)
Creates quality guidelines andwork instructions relevant for maintaining regulatory compliance
Ensures creation of adequatedocumentation for audits/inspections
Acts as a leader in the NAM QTRA/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 functionallyinfluence policy and guidelines in the U.S. regulatory environment
develops processes and systemsto deliver functional objectives
plans own work according totargets agreed, within a quarterly & up to an annual cycle, byintegrating resources in a project driven environment
provides functional advice andguidance to colleagues and customers
possesses a charteredprofessional 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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