PHYSICAL AND MENTAL REQUIREMENTS, WORKING CONDITIONS

• Learn new tasks, remember processes, maintain focus, complete tasks independently, make timely decisions in the context of a workflow, ability to communicate with others, ability to complete tasks in situations that have a speed or productivity quota.
• Travel quarterly, or as business need requires to Boulder, CO.
• Sedentary work. Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects. Position requires close visual acuity for preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading.

ABOUT THE ROLE

The Senior Specialist, Regulatory Affairs is the Regulatory Affairs representative and subject matter expert for our product teams supporting new product development and lifecycle management with a focus on domestic markets. This position is responsible for supporting the product development and regulatory submissions for in vitro diagnostic devices containing both software and chemistry. This is a role that would suit a regulatory professional who has experience focused on US regulatory requirements for IVDs and working with cross-functional teams during product development. This is a full-time position working standard business hours but may require the flexibility to work diverse schedules, including evenings, weekends, and occasional holidays. This position reports to the Senior Manager, Regulatory Affairs.

WHAT YOU WILL DO

• Support the preparation, submission, and maintenance of electronic/paper regulatory submissions according to applicable regulatory requirements and guidelines.
• Support the development and maintenance of technical files for In Vitro Diagnostic devices per local and global regulations.
• Provide regulatory input and guidance on US and global regulatory requirements throughout product development for in vitro diagnostics devices.
• Support cross-functional team in the application of relevant regulations and standards (e.g., IEC 62304, ISO 14971, ISO 13485).
• Work closely with R&D, Quality Assurance, Manufacturing, and Marketing teams to ensure regulatory requirements are integrated into the product development process.
• Evaluate updated regulatory requirements and help implement necessary adjustments to maintain compliance.
• Assess the acceptability of documents and product development activities for submission filing to comply with applicable regulations.
• Conduct gap analyses and audits to identify areas of non-compliance and recommend corrective actions.
• Support medical device reporting, post-market surveillance, and vigilance reporting per the regulations.
• Work closely with other Regulatory Affairs team members to develop processes and implement compliance standards as required by local/international regulatory requirements.
• Monitor and track the status of regulatory activities/projects and provide updates to leadership as needed.