Principal Regulatory Affairs Specialist

November 23, 2024

Apply Now

Description

β€’ Principle Regulatory Affairs Specialist responsible for regulatory strategy and compliance. β€’ Collaborate with R&D, Marketing, Quality, and other functions throughout product lifecycle. β€’ Lead project management and develop necessary SOPs for regulatory compliance.

Requirements

β€’ 6 years of experience in U.S. and global Class II or III medical device regulatory affairs (active implantable device is a plus) β€’ Submissions experience in medical devices, SaMDs, AI/ML-enabled medical devices, deep learning-enabled devices, and digital health software. β€’ Have experience in developing complex submissions. Strong organization and attention to detail. β€’ Work independently and cross-functionally with minimal supervision.

Apply Now

Similar Jobs

November 23, 2024

Business Wire

501 - 1000

BeiGene seeks a Director to manage regulatory strategies for companion diagnostics. Drive compliance and collaboration across teams and external partners.

πŸ‡ΊπŸ‡Έ United States – Remote

πŸ’΅ $212.2k - $292.2k / year

⏰ Full Time

πŸ”΄ Lead

πŸš” Compliance

November 22, 2024

Drive innovative compliance solutions at Datavant, a healthcare data platform. Serve as a key leader in the Compliance and Privacy team.

πŸ‡ΊπŸ‡Έ United States – Remote

πŸ’΅ $173k - $230k / year

πŸ’° $40M Series B on 2020-10

⏰ Full Time

πŸ”΄ Lead

πŸš” Compliance

πŸ¦… H1B Visa Sponsor

November 21, 2024

Lead compliance initiatives, frameworks, and programs for the company in the insurance sector.

November 21, 2024

Drive regulatory engagement and innovation for Notabene, shaping crypto policy and compliance.

November 20, 2024

Lead compliance team at CrossCountry Mortgage, developing strategies to ensure regulatory adherence and mitigate risks.

πŸ‡ΊπŸ‡Έ United States – Remote

πŸ’° $400M Debt Financing on 2021-11

⏰ Full Time

πŸ”΄ Lead

πŸš” Compliance

Built byΒ Lior Neu-ner. I'd love to hear your feedback β€” Get in touch via DM or lior@remoterocketship.com