Senior Regulatory Affairs Specialist
New
I
iRhythm TechnologiesMedical Devices
Remote - USFull-TimeSenior
Salary99,000 - 129,000 USD per year
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Job Details
- Experience
- 3 years of Regulatory Affairs experience
- Required Skills
- HIPAA
Requirements
- Bachelor’s degree (B.A./B.S. required)
- 3 years of Regulatory Affairs experience in the medical device industry
- Familiarity with global medical device regulations (e.g., 21 CFR 820, MDD/CMDR, EU MDR, UKCA)
- Demonstrated understanding of ISO 13485, ISO 14971, ISO 10993, GDPR, and HIPAA
- Product development or sustaining/life cycle management experience
- Exceptional communication (written and oral) skills
- Exceptional problem-solving skills
- Exceptional organizational skills
- Willingness to travel when required, up to 10%
Responsibilities
- Develop sound global, regional, and multi-country regulatory strategies for new and modified medical devices
- Prepare international and domestic filings/registrations to established timelines and company objectives
- Anticipate regulatory and related obstacles and emerging issues throughout the product lifecycle
- Interact with regulatory authorities during the development and review process to ensure submission approval
- Represent Regulatory Affairs on assigned projects and provide regulatory guidance to the cross-functional teams
- Coordinate with international contacts on product changes, regulatory notifications and registration/license maintenance
- Review and approve product design changes to maintain regulatory compliance for significant changes
- Author or revise SOPs to improve regulatory compliance of the Quality System
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