Senior Regulatory Affairs Specialist
Siemens Healthineers
full-time
Posted on:
Location Type: Hybrid
Location: Austin • Minnesota, Texas • 🇺🇸 United States
Visit company websiteSalary
💰 $93,680 - $140,520 per year
Job Level
Senior
About the role
- Collaboratively interface with a variety of levels on significant matters, often requiring coordination across organizational units.
- Outline submission and clearance requirements in assigned geographies.
- Develop sound regulatory strategies in alignment with business priorities and update strategies based upon regulatory changes.
- Review and approve R&D, quality, preclinical and clinical documentation for submission filing.
- Compile, prepare, review, and submit high-quality regulatory submissions to authorities on time in US, EU, and Canada.
- Interact and negotiate directly with regulatory authorities during development and review processes to ensure clearance/approvals.
- Evaluate proposed design, clinical, and manufacturing changes for regulatory impact and approve changes in compliance with regulatory requirements.
Requirements
- 5+ years of progressive experience in regulatory affairs, clinical and quality assurance preferably Class II and Class III medical devices.
- Must have experience with pre- and post-market medical device submissions such as 510(k), IDE, PMA, Presubmissions, DeNovos, EU Technical Files, and Design Dossiers.
- Experience in the use of clinical data to support regulatory submissions.
- Experience with international filings (Australia, Japan, China, Latin America etc.) is a plus.
- Strong knowledge of regulations and standards: 21 CFR Part 11/820, ISO 13485, ISO 14971, IEC 60601, IEC 62304, IEC 62366, ISO 10993.
- Educational background: Bachelor’s degree Engineering/ Life Sciences (advanced degree preferred)
- RAC certification (U.S. or EU) is a plus.
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
regulatory affairsclinical documentationquality assurancemedical device submissionsclinical data analysisregulatory strategy developmentsubmission filingregulatory impact evaluationinternational filingsregulatory compliance
Soft skills
collaborationnegotiationcommunicationorganizational skillsattention to detailproblem-solvingstrategic thinkingadaptabilityinterpersonal skillstime management
Certifications
RAC certificationBachelor’s degree in EngineeringBachelor’s degree in Life Sciencesadvanced degree in relevant field