Avanos Medical · 1 day ago
Senior Regulatory Affairs Specialist - Remote
United States
Full-time
Remote
Mid, Senior Level
$87K/yr - $145K/yr
4+ years exp
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Responsibilities
Regulatory Submissions and Documentation
Compliance and Post-Market Activities
Cross-Functional Collaboration
Regulatory Strategy and Guidance
Audits and Inspections
Qualification
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Required
Bachelor’s degree in a scientific, engineering, or medical field (e.g., Biology, Biomedical Engineering, Regulatory Science).
In-depth knowledge of MDR requirements, technical documentation, and post-market compliance activities.
Strong organizational and time-management skills to manage multiple priorities and deliverables.
Excellent written and verbal communication skills to convey regulatory requirements clearly to diverse stakeholders.
Analytical and critical thinking skills to assess regulatory risks and develop practical solutions.
Ability to work effectively with cross-functional teams and external partners to meet regulatory and business objectives.
High level of accuracy and thoroughness in regulatory submissions and documentation.
Ability to navigate complex and evolving regulatory landscapes effectively.
4 years of experience in regulatory affairs within the medical device industry or 2 years of experience with an advanced degree.
Extensive knowledge of EU MDR 2017/745, including technical documentation, clinical evaluations, post-market surveillance, and risk management requirements.
Proven experience in preparing and managing CE marking submissions and working with Notified Bodies.
Familiarity with global medical device regulations (e.g., FDA, ISO 13485, ISO 14971, MDSAP).
Experience in post-market regulatory activities, including vigilance reporting and field safety corrective actions.
Preferred
Advanced degree (Master’s or Ph.D.) is a plus.
Regulatory Affairs Certification (RAC) or equivalent certification is preferred.
Experience with digital health technologies, software as a medical device (SaMD), or combination products is an advantage.
Familiarity with additional global regulatory frameworks (e.g., China NMPA, Japan PMDA, Canada, Australia) is a plus.
Benefits
401(k) employer match of 100% of each pretax dollar you contribute on the first 4% and 50% of the next 2% of pay contributed with immediate vesting.
Benefits on day 1
Company
Avanos Medical
Avanos Medical is a medical technology company that delivers clinical products and solutions for healthcare industries.
1001-5000 employees
Funding
Current Stage
Public CompanyTotal Funding
unknown2018-07-02IPO
Leadership Team
Joe Woody
Chief Executive Officer
Recent News
2024-11-12
Company data provided by crunchbase
