Work Shift: DAYWork Schedule: Why Merit?
At Merit Medical, our mission is to create innovative medical devices that improve lives.Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitment.Together, we are making a difference in the lives of patients around the world.ESSENTIAL FUNCTIONS PERFORMED1.Collaborates with key stakeholders to ensure alignment of regulatory goals and objectives with the strategic priorities of the business.2.Develops and maintains strong strategic partnerships with project team members, including Marketing, R&D;, Operations, Clinical Affairs and Quality Assurance.3.Ensures all regulatory activities for assigned platform and operations projects comply with evolving global regulatory requirements.4.Maintains product knowledge within the team and ensures essential data is gathered and organized in support of global submissions.5.Partners 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.6.In collaboration with Regional RA, represents Merit effectively in interactions with Regulatory authorities, strengthening Merit's reputation and credibility.7.Supports and suggests continuous improvement of regulatory processes, procedures and policies.8.Ensures compliance with relevant regulatory requirements.9.Ensures project teams are informed of new and pending changes in regulation and evolving interpretation of regulation and how they will be impacted.10.Ensures the timely maintenance of regulatory data with a high degree of accuracy and compliance.11.Supports Regulatory Affairs in due diligence activities to ensure regulatory risks and integration needs are clearly articulated and understood.Coordinates with Regional RA on the integration of new acquisitions.12.Supports and when needed represents Regulatory Affairs in audits/inspections leading to successful outcomes.13.Performs other duties and tasks as required.ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDSLifting - Not to exceed 50 lbs.
- local practice may apply.Writing Sitting Standing Bending Visual acuity Color perception Depth perception Reading Field of vision/peripheral MINIMUM QUALIFICATIONSBachelors degree in life sciences, engineering, regulatory affairs or a related discipline.8 years of progressive Regulatory Affairs experience in the medical device industry.Demonstrated general knowledge of general medical device regulations, and various Quality System Standards/Regulations/Laws, including but not limited to ISO *****, etc., Design Controls, reviewing and approving project plans, qualification protocols/reports.Modern computer skills.Relevant regulatory certifications (e.g., RAC) strongly preferred.COMPETENCIESProject management Written and Verbal Communication Attention to Detail Continuous Improvement Analytical Skills Strategic leadership Team development Results oriented Integrity Organization COMMENTSInfectious Control Risk Category III: The risk category explains whether or not employees are likely to come into contact with blood or body fluids while performing their jobs.Risk category III states employment and procedures that do not require exposure.As an eligible Merit employee, you can expect the following: Multiple Shifts and Hours to choose from: Days, Swing (Eve), and Nights Medical/Dental & Other Insurances (eligible the first of month after 30 days)Low Cost Onsite Medical Clinic Two (2) Onsite Cafeterias Employee Garden | Gardening Classes3 Weeks' Vacation | 1 Week Sick-Time | Paid Holidays401 K | Health Savings Account To see more on our culture, go to 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)
🏢 Merit Medical Systems
📍 Tijuana