Principal Regulatory Affairs Specialist

3 weeks ago

Dallas, United States Merit Medical Systems Full time

Work Shift: DAY Work 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 PERFORMED * Determines and documents global regulatory pathways for various projects including product classification and type of regulatory submission or rationale required for new products and changes to existing products. * Works with engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies. * Prepares, delivers and defends regulatory submissions to the FDA, the Notified Body and other regulatory authorities and/or distributors. * Prepares documentation for Clinical Studies, as needed. * Reviews significant product and clinical study submissions with management and negotiate submission issues with agency personnel. * Provides support to currently marketed products as necessary by reviewing/approving labeling, promotional materials, and changes per policy and procedure. * Interact directly with the FDA and/or indirectly with international regulatory agencies on most products/projects at reviewer level; all significant issues will be reviewed with management. * Supports regulatory compliance activities, including manufacturing site registration, Notified Body audit, product recalls, etc., as needed. * Maintains proficiency in worldwide regulatory requirements; establishes and maintains positive relationships with agency personnel and/or Regulators. * Provides business and product information to international regulatory staffs to enable development of strategies and requirements, and communicates that information to management and project teams. * Provides feedback and on-going support to product development teams for regulatory issues and questions and informs management of status and developments on projects. * May develop, maintain, and analyze department systems and provide training. * May ensure personal understanding of all quality policy/system items that are applicable. * May assist with departmental policy implementation. Provides technical guidance and regulatory training/mentoring to other RA employees and cross- functional teams. * May identify relevant standards and guidance documents that affect Merit's business and products. * May assist with Regulator facility inspections. * May conduct internal audits, when directed. * May assist with risk management review and documentation. * Performs other related duties and tasks, as required. SUMMARY OF MINIMUM QUALIFICATIONS * Education and/or experience equivalent to a Bachelor's Degree in a technical field such as the biological, physical, engineering, or material science disciplines. * Seven years of relevant regulatory experience. * Demonstrated or verifiable experience with authoring regulatory submissions and interacting with reviewers. * Demonstrated knowledge of global regulatory requirements such as, U.S. FDA regulations, the Medical Devices Directive (93/42/EEC), Medical Device Regulation (2017/745), ISO 13485 Quality System Standard, ISO 14971 Risk Management, and Canadian Medical Device Regulation. * Self-motivated, self-directing, strong attention to detail and excellent time management skills. * Strong interpersonal skills and the ability to communicate well - verbally and in writing - with others. * Excellent analytical and problem-solving skills. * Demonstrated excellent in submission writing and preparation. * Demonstrated computer skills preferably spreadsheets, word processing, database, internet research and other applicable software programs. PREFERRED QUALIFICATIONS * Supervisory/mentoring and project management skills COMPETENCIES * Global knowledge of medical device regulations/law * FDA/Notified Body communication * Problem solving * Field Action coordination and reporting * Product development and change qualification processes * Regulatory submission/rationale preparation * Interpersonal/communication skills 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 Classes * 3 Weeks' Vacation | 1 Week Sick-Time | Paid Holidays * 401K | Health Savings Account To see more on our culture, go to www.merit.com/careers. Military Veterans are encouraged to Apply. Merit is a proud Utah Patriot Partner committed to hiring our Veterans.

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