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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.

Position Description

  • 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

KeyResponsibilities

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)

Knowledge

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.

Influence

Provide specialized guidance or train support and/or professional staff. Leadership qualities and role model qualities.

Impact

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.

Experience

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

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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