Prin Regulatory Affairs Spec - Exempt

Job Title: Principal Regulatory Affairs SpecialistJob Description The Principal Regulatory Affairs Specialist will lead and execute regulatory activities for a cerebral and somatic oximetry product portfolio within an acute care monitoring business. This role suits an experienced individual contributor who independently manages moderately to highly complex projects with limited supervision. You will set clear objectives that align with broader project goals, drive key regulatory milestones, and act as a subject matter expert across the organization. You will collaborate closely with cross-functional teams, influence product development and lifecycle strategies, and recommend improvements to systems and processes that enhance regulatory effectiveness and compliance. Responsibilities + Plan, lead, and execute regulatory strategies and activities for a cerebral/somatic oximetry product portfolio within an acute care monitoring environment. + Direct and perform the coordination, compilation, and preparation of document packages for regulatory submissions, internal audits, and inspections. + Lead and compile all materials required for US and EU submissions and tenders, including 510(k) submissions, Notified Body sampling, and EU MDR Technical Documentation. + Support regulatory submissions and responses to regulatory inquiries for global markets. + Collaborate closely with R&D, clinical, operations, and marketing teams to ensure regulatory requirements and strategies are fully integrated into product development and lifecycle management. + Recommend changes to labeling, manufacturing processes, marketing strategies, and clinical protocols to maintain regulatory compliance. + Review and provide regulatory input on promotional materials to ensure compliance with applicable regulations. + Monitor, update, and improve project tracking tools and US/EU distribution control systems to maintain regulatory oversight and traceability. + Proactively monitor and interpret evolving global regulatory requirements and communicate potential impact, risks, and opportunities to internal stakeholders. + Interact directly with regulatory agencies, including the FDA and EU Notified Bodies, on defined matters such as presubmissions and submissions. + Recommend regulatory strategies that support the earliest possible and most efficient path to market for new and modified products. + Support and, when needed, lead functional activities during internal and external audits and inspections. + Develop and deliver training on regulatory requirements, processes, and changes to cross-functional teams. + Mentor junior regulatory staff and provide onboarding support to new team members. + Participate in CAPA investigations when regulatory issues are identified, ensuring appropriate regulatory actions and documentation are completed. Essential Skills + Strong, hands-on experience preparing and managing 510(k) submissions, including presubmissions, for medical devices. + Demonstrated experience communicating directly with the FDA on regulatory matters such as presubs, submissions, and inquiries. + Extensive experience supporting medical devices that incorporate integrated software and require clinical evidence to support safety and effectiveness. + Proven experience reviewing and providing regulatory guidance on promotional materials for medical devices. + Ability to independently manage moderately to highly complex regulatory projects with limited supervision while meeting deadlines and milestones. + Strong collaboration skills with cross-functional partners, including R&D, clinical, operations, and marketing, to integrate regulatory strategy into product development and lifecycle management. + Ability to interpret and apply US and EU medical device regulations, including requirements for 510(k) submissions and EU MDR Technical Documentation. + Strong written and verbal communication skills to prepare clear regulatory documentation and effectively communicate with internal stakeholders and regulatory authorities. + Experience supporting or leading regulatory activities during internal and external audits and inspections. + Capability to mentor and guide junior regulatory professionals and support staff. Additional Skills & Qualifications + University degree with a minimum of 7 years of relevant regulatory affairs experience, or an advanced degree with a minimum of 5 years of relevant experience. + Experience working with global regulatory requirements beyond the US and EU. + Familiarity with Notified Body sampling processes and EU MDR expectations for technical documentation. + Experience participating in CAPA investigations related to regulatory issues. + Experience developing and delivering regulatory training to cross-functional teams. + Proven ability to recommend and implement improvements to regulatory systems, processes, and tracking tools. + Demonstrated leadership as an individual contributor, acting as a subject matter expert and role model within a regulatory affairs function. Work Environment The role operates within an acute care monitoring and medical device environment, focusing on a portfolio of cerebral and somatic oximetry products that integrate software and rely on clinical evidence. You will work closely with cross-functional teams such as R&D, clinical, operations, and marketing in a collaborative, project-driven setting. The position emphasizes independent work on complex regulatory projects, frequent communication with internal stakeholders, and regular interaction with regulatory authorities and notified bodies. The work involves extensive use of electronic documentation systems, project tracking tools, and distribution control systems to manage US and EU regulatory activities. The environment values continuous improvement, knowledge sharing, and mentoring, with opportunities to lead training, support audits and inspections, and influence regulatory strategy across the product lifecycle. Job Type & Location This is a Contract position based out of Remote, OR. Pay and Benefits The pay range for this position is $60.00 - $60.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: u2022 Medical, dental & vision u2022 Critical Illness, Accident, and Hospital u2022 401(k) Retirement Plan u2013 Pre-tax and Roth post-tax contributions available u2022 Life Insurance (Voluntary Life & AD&D for the employee and dependents) u2022 Short and long-term disability u2022 Health Spending Account (HSA) u2022 Transportation benefits u2022 Employee Assistance Program u2022 Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully remote position. Application Deadline This position is anticipated to close on Apr 17, 2026. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through: + Hiring diverse talent + Maintaining an inclusive environment through persistent self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for our people Actalent is an equal opportunity employer. About Actalent Actalent is a global leader in engineering and sciences services. For more than 40 years, weu2019ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APACu2014with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day. Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at .

Created: 2026-04-17