SR. REGULATORY AFFAIRS SPECIALIST

We are searching for an experienced regulatory professional to work within the Companion Diagnostics (CDx) team. Reporting to the Sr. Director, Regulatory Affairs (CDx), the successful candidate must have global regulatory experience working in IVD, Medical Devices, or Pharmaceuticals, with a history of successful regulatory submissions, registrations, 510(k)’s, and PMA approvals in the US and Asia. The preferred candidate has experience in Companion Diagnostics and has led company-sponsored interactions with regulatory bodies, especially the FDA. The candidate must have excellent oral and written communication skills and will represent Regulatory Affairs on project teams and in close collaboration with pharmaceutical partners. Responsibilities Provide expertise in regulatory affairs leading to the successful regulatory registrations and approvals of Companion Diagnostic products in global markets. Develop regulatory strategies related to CDx product development in collaboration with Regulatory Sr. Management. Provide regulatory assessments and plans for international product registrations and approvals. Collaborate with pharmaceutical partners in joint meetings. Ensure the accurate and timely preparation of regulatory submissions and reports in accordance with company goals, regulatory requirements, and partnership contracts. Work across the organization to ensure alignment of regulatory processes, standards, and compliance. Provide expertise and advice for obtaining CDx product registrations and approvals in the Pacific Asian market. Represent the company in third-party meetings, especially with the FDA, and in regulatory associations. Stay informed about global IVD regulations and guidances, especially those relevant to Companion Diagnostics. Qualifications include a Bachelor's or Master's Degree or equivalent. Typically, 8+ years of relevant experience are required for this level. Post-graduate studies and/or certifications/licenses may be required. This role requires specialized depth and/or breadth of expertise and is not a natural progression from an advanced level. Additional Information All your information will be kept confidential according to EEO guidelines. Direct Staffing Inc #J-18808-Ljbffr