DeepHealth is hiring a
Senior Regulatory Specialist
DeepHealth
π΅ ~$177k-$266k
πRemote - United States
Please let DeepHealth know you found this job on JobsCollider. Thanks! π
Summary
Join a dynamic team with expertise in various fields, collaborating in an agile work environment with continuous learning opportunities.
Requirements
- Bachelorβs degree in relevant field (or equivalent experience)
- Strong knowledge of FDA Quality System Regulations, including but not limited to, 21 CFR 11, and 21 CFR 820
- 6-8 years working in a regulated industry (FDA and Software as a Medical Device preferred)
- Knowledge and experience drafting and submitting regulatory filings, including but not limited to, Q-Submission requests
- Experience with US FDA Class I and II medical devices
- Excellent written and oral communication skills
Responsibilities
- Plan, define and coordinate relevant process related to product Regulatory approval
- Actively liaise and closely collaborate with engineering and product teams to ensure regulatory compliance for product markets
- Provide regulatory guidance to the development teams for registration of products
- Create and ensure maintenance of technical documentation (such as clinical evaluation reports, risk management reports, 510(k) notification)
- Plan, execute and document (clinical) risk assessment sessions with relevant internal and external experts
- Work with the clinical teams to ensure compliance for pre- and post-market clinical studies in support of DeepHealth products and product changes
- Enforce compliance to applicable standards and escalate to appropriate authorities if needed
- Ensuring timely submission of adverse events to the appropriate regulatory bodies
Benefits
- Fully remote working environment with Flexibility in work hours
- A salary in line with job level and experience
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