Senior Regulatory Affairs Specialist

hace 1 semana


Tijuana, México Merit Medical A tiempo completo

**SUMMARY OF DUTIES**

This position is responsible for the creation, support, and improvement of global regulatory operations, systems, and processes. Performs duties with limited input from management of the department.

**ESSENTIAL FUNCTIONS PERFORMED**
- Supervises the process of determining global strategies for various field action activities and provides proposals to RA leadership team.
- Coordinate and execute global field actions, per internal policies and procedures.
- Develop, maintain, and update field action files per internal policies and procedures.
- Coordinate and prepare complex documents to support regulatory submissions and certifications as requested.
- Develop, maintain, and improve global regulatory processes, systems, and procedures, and provide training when needed.
- Work closely with global functions and departments to integrate processes and meet global regulatory needs.
- Provide updates to, and interact with, various levels of management, external agencies, and customers as requested.
- Prepare technical, complex correspondence to FDA, Competent Authorities and other regulatory authorities as requested.
- Participate in and assist with FDA facility inspections, Notified Body Audits and other inspections and audits as directed.
- Remain current with global regulations, guidance documents, and standards and develops plans for global implementation, integration, and training when needed.
- Assists with supervision of department staff, as directed.
- Perform other 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 in the biological, physical, engineering, material science, regulatory, or legal disciplines.
- Six years of experience in a related technical field such as engineering, quality, regulatory, legal, etc..
- Demonstrated experience with US, EU, and Canada medical device field actions.
- Demonstrated experience with US, EU, and Canada medical device regulatory submission regulations and directives.
- Demonstrated experience with ISO 13485 and other quality system international standards.
- Demonstrated experience with project management, process development, and process improvement.
- Strong technical writing skills.
- Self-motivated, self-directing, strong attention to detail and excellent time management skills.
- Ability to manage projects efficiently and effectively to meet deadlines.
- Excellent interpersonal skills and the ability to communicate well - verbal and written.
- Strong computer skills: spreadsheets, word processing, database, research, and other applicable software programs.

**PREFERRED QUALIFICATIONS**
- Project management certifications

**COMPETENCIES**
- Analytical, critical, and strategic thinking
- Problem-solving
- Interpersonal/communication/training skills
- Technical writing
- Project management
- Process development
- Process improvement
- Supervisory process
- Computer, software, database skills

MERIT MEDICAL SYSTEMS, INC.

EQUAL OPPORTUNITY EMPLOYER M/F/D/V

LI-MM1

**Requirements**:
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