Hiring: Director, Business Development Regulatory Affairs Company: Olympus Corporation Location: Greater Boston Job Posted Time: 2026-09-11 12:35:44 Employment Type: Full-time / Remote Target Skills & Keywords : Embedded Systems, Project Management, R About the job Experience: •100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling. •15 year of directly related Regulatory Affairs experience; preferably at least 10 years in a global role. •100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world. •At least 10 years in a global role. Required Skills: •The Director, BD Regulatory Affairs is responsible for strategic and tactical functional support for business development projects. This important role will be a key partner to the global BD team, ensuring that the function’s perspective is embedded in diligence and integration efforts. •Serve as the global liaison between RA and the BD team. •Lead and oversee providing in-depth analysis of Medical Device/Healthcare quality management system functionality and maintenance to contribute to transfer of business activities. •Provide strategic guidance on global regulatory pathways and market access planning. •Accountable for developing, maintaining, and executing a RA M&A readiness plan. •Assess current capabilities, systems, policies, processes, organizational structure, and resources for conducting RA due diligence, integration strategy/planning activities, and integration execution against best practices. •Tool & Process Development and Continuous Improvement: Create the tools and standard operating processes necessary to support RA efforts throughout the full business development cycle (pre deal through integration), including ownership of assigned deliverables. •Develop a clear implementation plan, agreed to by BD and RA senior leaders. Qualifications: •Bachelor’s degree in a science-related discipline. Masters preferred. •Minimum of 15 year of directly related Regulatory Affairs experience; preferably at least 10 years in a global role. •Knowledge of and experience managing a Quality Management System and leading external QMS certification/surveillance audits. •Thorough understanding of global submission requirements and appropriate design control requirements in order to satisfy global Health Authority submission standards. •In-depth knowledge of global quality and regulatory requirements for the development of new product and maintenance support for sustaining market access. •Demonstrated ability to work cross-functionally. •Demonstrated ability to lead programs/projects. •Has sense of passion, drive and perseverance to accomplish goals. •Global understanding of product domains and key technology/therapeutic area/R&D disciplines. •Excellent leadership and interpersonal skills, including the ability to work across cultures and personality types. Compensation: •$134,666 - $188,532 / year •Flexible work environment (work from home / hybrid options) •Competitive salaries, annual bonus and 401(k)* with company match Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!