Regulatory Affairs Professional

Job Description

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: 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; acts 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.

Position Description:
  • 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 in all interactions with FDA (e.g., meetings, teleconferences, and in writing)
  • 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
  • Ensures creation of adequate documentation for audits/inspections
  • May represent the company in industry associations (e.g. – MITA, AdvaMed, etc.)
  • May create quality guidelines and work instructions relevant for maintaining regulatory compliance

Key Responsibilities
Using professional expertise, with extensive functional, commercial and/or technical knowledge in regulatory affairs:
  • Develops processes and systems to deliver functional objectives
  • Plans own work according to agreed targets by integrating resources in a project driven environment
  • Provide functional advice and guidance to colleagues and internal/external customers
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. 

Provide specialized guidance on pre-market topics (e.g., submissions, advertising & promotion, etc.) in the U.S.

Is expected to adopt existing concepts, methodologies, etc., to fulfill specific internal and external client requests or project requirements.

  • 3 - 5 years of experience in medical device regulatory affairs (experience with 510(k), PMA, QSR, etc.). Imaging experience is a plus.
  • Successful demonstration of Key Responsibilities, Knowledge, Influence & Impact as presented above
  • Possesses a chartered professional qualification (e.g., RAC, etc.) or equivalent.

Organization: Siemens Healthineers

Company: Siemens Medical Solutions USA, Inc.

Experience Level: Mid-level Professional

Job Type: Full-time

Equal Employment Opportunity Statement
Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.

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