[Remote] Regulatory Affairs Professional (Remote)

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

Company H1B Sponsorship