Regulatory Affairs Professional
Siemens Healthineers
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $98,140 - $134,937 per year
About the role
- 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
Requirements
- Bachelor’s degree in scientific discipline
- Advanced degree preferred
- Minimum of 5 years of experience in medical device industry
- Experience with medical device regulatory submissions is preferred
- Skilled in Outlook, SharePoint, Adobe Acrobat and Microsoft Office applications, including Excel
- Intercultural sensitivity
- Strong attention to detail and excellent organizational skills
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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory strategyregulatory dossiersTechnical FilesFDA marketing submissionsPMA510(k) Pre-Market NotificationsPre-Submissionslabeling reviewsR&Dclinical study design
Soft Skills
intercultural sensitivityattention to detailorganizational skills
Certifications
Bachelor’s degreeadvanced degree