Principal Regulatory Affairs Specialist - Remote

Overview

The Principal Regulatory Affairs Specialist is responsible for supporting regulatory strategy development, worldwide product approval submission activities and for ensuring regulatory compliance. This person is responsible for implementing policies, procedures, and practices for Regulatory Affairs.

In Short

• Participate in Product Development teams providing input on regulatory strategies.
• Write and compile regulatory submissions including IDEs, QSubmissions, PMAs.
• Lead regulatory project management and drive submissions to approval.
• Create SOPs and work instructions for regulatory compliance.
• Advise the internal team on regulatory requirements for submissions.
• Contribute to streamlined workflows and timely submissions.
• Lead initiatives to educate and train the team on regulatory processes.
• Manage multiple projects in a fast-paced environment.
• Develop relationships with regulatory advisors and consultants.

Requirements

• 6 years of experience in medical device regulatory affairs.
• Experience with submissions in medical devices and digital health software.
• Strong organization and attention to detail.
• Ability to work independently and cross-functionally.

Benefits

• Work with a dynamic, multi-disciplinary team.
• Contribute to life-changing technologies.
• Supportive work culture.