Senior Global Regulatory Affairs Specialist

Jenavalve Technology Inc

Irvine (CA)

On-site

USD 110,000 - 140,000

Full time

14 days+

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Job summary

Jenavalve Technology Inc in Irvine, CA is seeking a Senior Specialist, Regulatory Affairs to lead global submissions for investigational device authorizations and registrations. You will interact with regulatory authorities and translate regulatory requirements into practical plans.

Under supervision, you provide guidance to project teams and ensure timely, scientifically valid submissions. The role requires experience with medical device regulations, quality systems, and strong writing and

Qualifications

Experience applying global medical device regulations and product development processes.
Comprehensive knowledge of quality systems and their relation to business.
Ability to interpret regulatory standards and guidance and provide direction to project teams.

Responsibilities

Lead the preparation, submission, and maintenance of high-quality global filings for investigational device approvals and registrations.
Serve as regulatory team member on product development and sustaining teams; drive global regulatory requirements into development processes.
Review labeling and documentation for compliance with global regulations and coordinate with authorities during audits.