• research compliance with all mortgage banking laws, rules, regulations, and prescribed policies/procedures • assess how regulatory changes might affect the company • provide recommendations about necessary policy and procedural changes • oversee monthly regulatory compliance weaknesses and work with management • contribute to the compliance training program • monitor federal and state regulatory sources for new rules • draft compliance alerts and maintain a regulatory change log • summarize complex regulatory changes for operations and leadership • prepare reports and meeting materials for compliance reviews • assist in implementation of compliance policies and procedures • respond to compliance-related inquiries from other departments

• Manage and support PDS internal audit program, identify trends, risks, and areas of improvement • Assess bidding compliance to support the Audit Control Plan • Report findings to client on a monthly basis • Support Regional PDS Teams through monthly compliance checks and follow-ups • Monitor and respond to process changes that impact business rules driving the Client GSA

• Serving as the primary U.S Regulatory expert for promotional materials through Immatics’ pipeline and any future commercial launches • Chair and lead PRC, ensuring “fair balance,” alignment with Prescribing Information (PI), and compliance with scientific exchange and misbranding rules • Ensure U.S advertising and promotional strategy consistency with FDCA, FDAMA, FD&C labelling, and OPDP guidance • Prepare and file pre-clearance materials via Form FDA 2253, lead OPDP interactions, and respond to enforcement letters/advisories • Support label negotiations for PI, carton/container, and PPI • Review advertising copy, promotional claims, speaker programs, digital/social media materials, and HCP-facing promotions for FDA compliance • Identify and remediate claims, manage recall and mitigation activities when necessary • Mentor junior RA professionals; oversee operational delivery and resource allocation • Manage budget for Ad/Promo activities and ensure cohesive execution across programs

Role Description The Staff Regulatory Affairs is responsible for driving compliance through regulatory change and regulatory intelligence activities including but not limited to identification, interpretation, assessment, and project management of changes. The purpose of this role is to maintain compliance with regulatory requirements on products and business systems and avoid audit observations and shipping delays. This position reports to the Senior Manager, Regulatory Affairs and is part of the Global Quality and Regulatory Affairs team and will be fully remote. In this role, you will have the opportunity to: - Monitor and analyze global regulatory intelligence across: IVD and medical device regulations (e.g., EU IVDR, US FDA regulations and guidance), AI/Software regulations, Chemical and environmental regulations (e.g., EU REACH, RoHS, PFAS, EPA, EU CLP requirement). - Develop detailed assessments of regulatory changes, providing actionable insights and impact analyses for internal stakeholders. Create business cases for regulatory-driven changes, including cost, resource, and timeline impact for compliance activities. - Support global regulatory strategy development by providing intelligence-driven recommendations. Maintain regulatory intelligence repositories, dashboards, and communication tools. - Prepare and deliver regulatory intelligence briefings, cross-functional reports, and executive summaries. - Leverage AI-enabled tools to automate horizon scanning and early detection of regulation changes. - Lead compliance gap analyses and risk assessments to proactively identify areas of regulatory exposure and develop mitigation plans in partnership with Quality and Legal teams. Ensure alignment with internal SOPs and global regulatory standards. Qualifications - Master’s degree in life sciences, engineering, or related field; advanced degree preferred. - 10+ years of experience in regulatory affairs or regulatory intelligence within the IVD/medical device industry. - Strong knowledge of global IVD regulations including FDA, EU IVDR, ISO 13485, ISO 20916, and related standards. - Demonstrated experience managing regulatory compliance programs, including compliance tracking systems, and audit readiness activities. - Experience implementing regulatory intelligence systems or digital tools. - Experience with AI/software or chemical/environmental regulations strongly preferred. - Experience interacting with regulatory agencies or notified bodies is a plus. Requirements - Previous experience in a regulatory intelligence role handling gap assessment and/or coordinating remediations is a plus. Benefits - Comprehensive, competitive benefit programs that add value to our lives. - Health care programs and paid time off. - Flexible, remote working arrangements for eligible roles.