Director of Regulatory Affairs - Remote

For our client, we are seeking a Director of Regulatory Affairs to join the team of a leader in the Healthcare space. This role will lead regulatory strategy and execution for medical device products across their lifecycle, with a strong emphasis on compliance, documentation, and cross-functional partnership. The director will provide practical regulatory guidance to product, quality, and business teams while helping ensure alignment with evolving FDA and international requirements. This is a highly visible position that will also support inspections, submissions, labeling review, and enterprise-wide communication on regulatory topics. Location: Remote - US based candidates only, no visa sponsorship available Compensation: $134,600 – $230,800 annually Responsibilities Lead and draft regulatory product assessments and deliverables Prepare and support regulatory plans and strategies as needed Provide expert regulatory advice through the product lifecycle Communicate regulatory topics effectively across the enterprise Review and guide labeling and promotional communications Analyze and disseminate regulatory intelligence on evolving requirements Support compliance activities including site registrations and inspections Prepare or support regulatory submissions as necessary Develop training materials on medical device regulatory topics Engage in trade associations on medical device issues Qualifications 10+ years of experience in medical device regulatory affairs or a related field Proven experience in regulatory documentation, including FDA and EU filings Experience with regulatory compliance activities such as audits and product recalls Familiarity with electronic quality management systems Expertise in medical device regulations, including FDA, ISO 13485, and IEC 62304 Ability to provide strategic regulatory advice in a changing industry Excellent communication skills for interacting with cross-functional teams and regulatory agencies Demonstrated ability to manage multiple regulatory projects and priorities Benefits Comprehensive benefits package Incentive and recognition programs Equity stock purchase options 401k contributions Flexibility to work remotely from anywhere in the U.S., with specific in-office requirements for certain locations 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.