The Position Manage activities associated with regulatory approval of in vitro diagnostic medical devices. Responsible for activities which lead to and maintain domestic and international regulatory approval to market devices. Responsible for assessment of device changes for regulatory implications. Responsibilities: Provides support to currently marketed products, e.g., review engineering changes, labeling, promotional material, product changes and documentation for compliance and for changes requiring regulatory agency approval, as pertains to US and international regulatory requirements. Responsible for maintenance of product technical files and for ongoing activities related to compliance with Global Regulatory directives and regulations. Manages submission activities for a variety of device regulatory approvals including the CE mark, US premarket approvals (PMAs), US premarket notifications (510(k)s), post-approval reports, annual reports, export certificates, and establishment registrations and device listings. For CDx or Lifecycle Support areas have responsibility for creation and submissions of US FDA pre-submissions, 510(k)s and PMAs for assigned projects. For International area ensures overall compliance with international standards and directives. Responsible for activities which lead to and maintain international regulatory approval to market devices. May review, interpret, and report Regulatory leadership on product specific regulatory issues that may have material impact on the business units, the corporation, or the customer. May work with Regulatory Affairs leadership to develop strategic and tactical responses to influence a reasonable regulatory environment. Acquires and maintains current knowledge of applicable regulatory requirements and scientific/technical issues in the geographic and discipline as relevant to assigned projects. Interfaces with regulatory authorities on regulatory and technical matters, as appropriate. Manages the creation and review of Standard Operating Procedures and policy guidelines for the regulatory affairs department. Provides regulatory support on project teams. Serves as Functional Lead on project team(s). May provide consultative and training support to the business unit and core regulatory personnel related to premarket submissions, product labeling, and complex submissions issues. May perform other duties as required or assigned. Other duties as assigned by management. Minimum Qualifications: B.S./B.A. in a science, engineering, or related technical field; advanced degree preferred 5 years experience in regulatory, development, clinical affairs, quality, or program management in IVD, medical device, or pharma industries. Regulatory Affairs experience is preferred. IVD device experience is preferred. Experience with Microsoft based applications and general knowledge of PC functions necessary. Preferred Qualifications: Proven experience in managing budgets is preferred. Experience with regulatory submissions including IDE, 510(k), and PMA submissions is preferred. For CDx experience with submissions for: IND, NDA/BLA or pharma experience preferred. Pharma clinical/statistical/regulatory experience in oncology, immunology or related field a plus. Travel Requirements: 25% This role is fully remote. No relocation assistance provided. For Colorado-based applicants, the expected salary range for this position is $100,000-115,000. Actual pay will be determined based on experience, qualifications, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits listed below. Benefits Roche offers highly competitive benefit plans and programs, including: •Medical, dental and vision insurance •401(k) and 401(k) matching •Paid time off •Roche Long Term Incentive Plan (available at certain position levels) Who we are At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity. Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, innovates and manufactures instruments and reagents that automate tissue processing and slide staining for cancer diagnostics. Our integrated staining, workflow management and digital pathology solutions optimize laboratory efficiency to reduce errors and support diagnosis for pathology professionals. Together with Roche, Ventana is driving personalized healthcare through accelerated drug discovery and companion diagnostics. Unless entitled to a reasonable accommodation under applicable law, employees are required to be fully vaccinated against COVID-19 in accordance with customer requirements, the company’s health and safety obligations and/or applicable law or guidelines. Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law. If you have a disability and need an accommodation in connection with the on-line application process, please email us at US.Accommodation@roche.com.