Regulatory Systems Specialist II

3 weeks ago

Philadelphia, United States Merit Medical Systems Full time

Reference #: JR108442 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.

WORK SHIFTDAY (United States of America)

SUMMARY OF DUTIESThis position is responsible for the creation, support, and improvement of global regulatory operations, systems, and processes.

ESSENTIAL FUNCTIONS PERFORMED

Develop, maintain, and update systems and databases per internal policies and procedures. Data validation of Regulatory Affairs Systems accurately and within established timelines.

Participate in data cleansing operations to facilitate appropriate and timely access to data for systems.

Develops, maintains, and improves various global regulatory processes and systems.

Works closely with global functions and departments to integrate processes and meet global regulatory needs.

Develops project plans as assigned. Tracks the staging of activities and milestones in regulatory work plans. Direct and manage project work processes.

Creates and provides training on regulatory systems across the organization as needed.

Identifies the need for new or revised procedures, user manuals, and data standards; ensures regulatory compliance and participates in development and implementation.

Provide updates to, and interact with, various levels of management, external agencies, and customers 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 assist with global implementation, integration, and training when needed.

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 Computer Science, biological, physical, engineering, material science, regulatory, or related field disciplines.

Three years of experience in a related technical field such as computer science, data management, engineering, quality, regulatory, legal, etc.

Demonstrated knowledge in data entry and data management.

Demonstrated knowledge of Regulatory Affairs in related industries (e.g., medical device, pharmaceutical, or nutraceutical).

Demonstrated experience in generating and analyzing complex system queries and reports.

Demonstrated experience with project management, process development, and process improvement.

Experience in Regulatory Information Management (RIM) Systems a plus.

Intermediate technical writing skills.

Self-motivated, self-directing, strong attention to detail and time management skills.

Excellent interpersonal skills and the ability to communicate well - verbal and written.

Strong computer skills: RIM systems, spreadsheets, word processing, database, research, and other applicable software programs.

PREFERRED QUALIFICATIONS

Prefer PMI CAPM/PMP Certification

Experience in Medical Device Regulatory Affairs or Regulatory Operations is strongly preferred.

Experience with a RIM system is strongly preferred.

COMPETENCIES

Analytical, critical, and strategic thinking

Problem-solving

Propensity to learn

Interpersonal/communication/training skills

Technical writing

Project management

Process development

Process improvement

Computer, software, database 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

4 1K | 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.

EQUAL OPPORTUNITY EMPLOYER M/F/D/V. Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled

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