Hiring: Prin Regulatory Affairs Specialist Company: IntePros Location: Lafayette, CO Job Posted Time: 2026-09-14 13:06:03 Target Skills & Keywords : R, Regulatory Compliance, Risk Management About the job Experience: •7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience. •Minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience. Required Skills: •Collaborative, solution-oriented performer focused on bringing value to stakeholders and the organization •Proven ability to develop and execute on robust regulatory strategies •Proven experience authoring and leading 510(k) submissions and EU Change Notifications. •Strong experience compiling MDR Technical Documentation •Strong experience reviewing promotional materials for US/EU markets •Strong knowledge of EU MDR, ISO 10993-1, ISO 13485, and ISO 14971 risk management principles. •Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections. •Leads and compiles all materials required for US and EU submissions and tenders, including 510(k) submissions, NB sampling, and EU MDR Technical Documentation. Qualifications: •Strong experience with class I and II electrical and software-based devices including applicable standards. •Strong experience with 510(k)s and presubs, and experience communicating directly with FDA •Strong experience with medical devices that have integrated software with clinical based supporting evidence •Strong experience reviewing promotional materials •The Principal Regulatory Affairs Specialist (Pr. RAS) is responsible for collaborating, planning and executing regulatory activities related to the INVOS™ (BIS™) Cerebral/Somatic Oximetry product portfolio within the Acute Care and Monitoring operation unit. •This role is fit for an established, productive individual contributor and leader who works independently on moderately to highly complex projects or programs with limited general supervision. •In the position, you will set objectives for your own work to align with broader project goals and actively contribute to key milestones. You will also participate in cross-functional activities, requiring awareness of wider organizational issues. •Recommend and own improvements to systems and processes to enhance effectiveness and regularly communicate with internal stakeholders to share updates, gather input, and support decision-making. You will function as a subject matter expert within the organization and as an individually contributing leader. •As such, you serve as a role model and may also guide entry-level professionals or support staff, eventually offering direction and assistance when needed. 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!