Principal Regulatory Affairs

For our client, we are seeking a Principal Regulatory Affairs to join the team of a leader in the Healthcare space. This role will guide regulatory strategy and execution for medical device submissions across pre-market and post-market activities. You will partner closely with internal stakeholders and external regulatory agencies to support market approvals, maintain compliance, and strengthen the quality of product documentation. The position also plays a key role in improving processes, addressing non-conformances, and supporting labeling and claims across multiple markets. Location: Remote - US based candidates only, no visa sponsorship available Compensation: $116,000 – $174,000 annually Responsibilities Determine requirements for product submissions and regulatory filings for market approvals. Communicate regulatory requirements to internal and external stakeholders. Review supporting evidence to ensure compliance with regulatory standards. Lead internal and external groups to complete regulatory filings and address non-conformances. Manage complex projects by defining timelines and correcting process deficiencies. Develop and substantiate product labeling and claims for various markets. Proactively improve regulatory-driven processes and maintain compliance databases. Qualifications B.A. or B.S. in life sciences, engineering, medical technology, regulatory science, or a related field. 5+ years of diverse regulatory experience in the medical device industry. Experience with pre- and post-market regulatory activities and independent submissions. Proficiency in authoring regulatory submissions, including 510(k)s and CE Technical Files. Strong communication and negotiation skills with regulatory agencies, including FDA. Benefits Health insurance and life/disability coverage. 401(k) contributions with company match. Paid time off and employee assistance programs. Continuing education and training opportunities. Access to Employee Resource Groups and Service Corp. Our client is an equal opportunity employer. We encourage you to apply even if you don’t meet every qualification—your background could be exactly what this team needs.