Sr. Regulatory Affairs Professional
The Regulatory Affairs
(RA) Professional role supports the Siemens Healthineers Advanced Therapies 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 AT IN RCW US management in the U.S. and the SHS AT QT RA management in Germany. 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.
Please note that this role can be remote based.
- 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
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
Deep professional know-how and experience in 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.
Technical knowledge of medical devices, endovascular robots, and imaging products especially of angiography and fluoroscopic systems (fixed and mobile c-arms systems) as well as experience in interventional procedures is preferred.
This position can be remote or preferably based
in the Malvern, PA or Newton, MA.
Domestic and international travel will be between 5% and 10% depending on location, to attend internal workshops, medical conferences, and to support North American regulatory submissions.
Siemens Healthineers has recently announced the next steps in our continued commitment to prioritize colleague health, comply with customer/business partner requirements, and help preserve our business continuity. Going forward, please be aware that Siemens Healthineers requires full vaccination for COVID-19 for our U.S. employees, contractors, and business partners, where local conditions allow, who:
1) Are customer-facing (e.g., those required to visit a customer/business partner site or interact in-person with customers at any conference or meeting) OR
2) Come on-site, whether regularly or occasionally, at any Siemens Healthineers location.
(Note: Accommodations may be requested for certain medical or religious reasons)
At Siemens Healthineers, we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry. What unites and motivates our global team is the inspiration of our common purpose: To innovate for healthcare, building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services. We recognize that taking ownership of our work allows both us and the company to grow. We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally.
If you want to join us in transforming the way healthcare is delivered, visit our career site at https://usa.healthcare.siemens.com/careers.
If you wish to find out more about the specific before applying, please visit: https://usa.healthcare.siemens.com/about.As an equal-opportunity employer we are happy to consider applications from individuals with disabilities.
Organization: Siemens Healthineers
Company: Siemens Medical Solutions USA, Inc.
Experience Level: Experienced Professional
Job Type: Full-time
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