Work Shift: DAYAt Merit Medical, we create innovative medical devices that improve lives.Essential Functions PerformedExemplify an engaged culture that is tied to the Merit Way and the RA Manifesto.Collaborate with key stakeholders to ensure alignment of regulatory goals and objectives with the strategic priorities of the business.Develop and maintain strong strategic partnerships with project team members, including Marketing, R&D;, Operations, Clinical Affairs and Quality Assurance.Ensure all regulatory activities for assigned platform and operations projects comply with evolving global regulatory requirements.Maintain product knowledge within the team and ensure essential data is gathered and organized in support of global submissions.Partner with the Regional RA team in the development, alignment and execution of regulatory strategies for platform and operations projects and changes, upholding rigorous standards of accuracy, timeliness, compliance and excellence in regulatory strategy.In collaboration with Regional RA, represent Merit effectively in interactions with regulatory authorities, strengthening Merit's reputation and credibility.Support and suggest continuous improvement of regulatory processes,



procedures and policies.Ensure compliance with relevant regulatory requirements.Inform project teams of new and pending changes in regulation and evolving interpretation of regulation and how they will be impacted.Ensure the timely maintenance of regulatory data with a high degree of accuracy and compliance.Support Regulatory Affairs in due diligence activities to ensure regulatory risks and integration needs are clearly articulated and understood; coordinate with Regional RA on the integration of new acquisitions.Support and when needed represent Regulatory Affairs in audits/inspections leading to successful outcomes.Perform other duties and tasks as required.Essential Physical/Environmental DemandsLift up to 50 lbs.Perform writing, sitting, standing, and bending tasks.Maintain visual acuity, color perception, depth perception, reading, and field of vision/peripheral.Minimum QualificationsBachelor's degree in life sciences, engineering, regulatory affairs or a related discipline.General knowledge of general medical device regulations.Relevant regulatory certifications (e.G., RAC) strongly preferred.CompetenciesWritten and verbal communicationAttention to detailContinuous improvementAnalytical skillsTeamworkIntegrityOrganizationBenefitsMultiple shifts and hours to choose from: days, swing (evening), and nights.Medical, dental and other insurances (eligible the first of the month after 30 days).
Low‐cost onsite medical clinic.Two onsite cafeterias.Employee garden and gardening classes.Three weeks of vacation, one week of sick time, and paid holidays.401(k) and health savings account.Infectious control risk category III: employees are not expected to come into contact with blood or body fluids while performing their jobs.Military Veterans are encouraged to apply.
Merit is a proud Utah Patriot Partner committed to hiring our Veterans.
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📌 Senior Platform Regulatory Specialist (Tijuana)
🏢 200 Merit Maquiladora Mexico, De C.V.
📍 Tijuana