[Remote] Regulatory Affairs Professional (Remote)

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Note: The job is a remote job and is open to candidates in USA. Siemens Healthineers is a leader in medical technology, dedicated to pioneering breakthroughs in healthcare. The Regulatory Affairs Professional will lead the development and execution of global regulatory strategy, prepare regulatory submissions, and act as a subject matter expert on regulatory requirements for new products.


Responsibilities

  • Leading development and execution of global regulatory strategy in collaboration with interdisciplinary product teams in compliance with international regulatory requirements and the Quality Management System
  • Preparing, submitting, and managing regulatory dossiers required for new product marketing and modified product applications in a global market
  • Preparing, submitting, and managing Technical Files in compliance with the requirements of the European Union (EU IVDR)
  • Prepare, submit, and manage FDA marketing submissions including PMA (including Annual Reports and Supplements), 510(k) Pre-Market Notifications, and Pre-Submissions
  • Acting as a Regulatory Affairs subject matter expert on new product introduction and design control teams
  • Advising teams on regulatory requirements including labeling reviews, R&D and clinical study design, and design change regulatory impacts
  • Participating in internal and external quality system and design dossier audits

Skills

  • Bachelor's degree in scientific discipline
  • Minimum of 5 years of experience in medical device industry
  • Skilled in Outlook, SharePoint, Adobe Acrobat and Microsoft Office applications, including Excel
  • Solid working knowledge and experience of the US/EU regulations and standards applicable to medical device market applications
  • Knowledge of IVD products and applicable regulations for such products
  • Very good presentation skills
  • Team orientation and communication skills
  • Excellent attention to details
  • Able to multi-task and work effectively in a dynamic environment
  • Intercultural sensitivity
  • Strong attention to detail and excellent organizational skills
  • Advanced degree preferred
  • Experience with medical device regulatory submissions is preferred

Benefits

  • Medical insurance
  • Dental insurance
  • Vision insurance
  • 401(k) retirement plan
  • Life insurance
  • Long-term and short-term disability insurance
  • Paid parking/public transportation
  • Paid time off
  • Paid sick and safe time

Company Overview

  • Siemens Healthineers is a healthcare technology company that provides diagnostic and therapeutic products and services. It is a sub-organization of Siemens. It was founded in 1847, and is headquartered in Malvern, Pennsylvania, USA, with a workforce of 10001+ employees. Its website is

    • Company H1B Sponsorship

  • Siemens Healthineers has a track record of offering H1B sponsorships, with 104 in 2025, 70 in 2024, 64 in 2023, 89 in 2022, 50 in 2021, 86 in 2020. Please note that this does not guarantee sponsorship for this specific role.

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