828A - Senior Regulatory Affairs Specialist (Annual)

Full Job Description

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.

SUMMARY OF DUTIES

Responsible for coordinating, preparing, and maintaining regulatory submissions and documents on a global level for Europe, the United States, and other countries. Primary responsibilities are to ensure regulatory compliance for assigned product lines Other responsibilities include coordinating recalls, identifying relevant standards and guidance documents that affect Merit’s business and products, assisting with FDA facility inspections, Notified Body audits, and other internal audits. Performs duties with limited input from management and/or senior members of the department.

DUTIES & RESPONSIBILITIES

• Determines global regulatory pathways for various projects including product classification and type of regulatory submission or rationale required. 
• Participates on various teams to define regulatory requirements of U.S. and international submissions, Technical Files or regulatory rationales.
• Identifies guidance documents, international standards, Consensus Standards and assists teams with their interpretation.
• Prepares regulatory submissions to the FDA, the Notified Body and other regulatory authorities.
• Prepares IDEs and PMAs and assists with clinical trials when required.
• Interacts with various levels of management, external agencies and companies.
• Analyzes and makes recommendations regarding field complaints.
• Develops, maintains and analyzes department systems and provides training when needed.
• Remains current on developing regulations and revises systems as necessary.
• Participates in and assists with FDA facility inspections, Notified Body Audits and other inspections and audits as directed.
• Assists with supervision of department staff, as directed.
• Provide MDSAP audit support plant network for Australia, Brazil, Japan.
• Support Product Transfers to ensure continued registration of products transferred with no loss of certification (business impact) throughout the transfer process.
• 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 and six years of related industry experience.
• Demonstrated knowledge of U.S. FDA regulations, the Medical Devices Directive (93/42/EEC, as amended), and various Quality System Standards/Regulations/Laws, including but not limited to ISO 13485, etc.
• Demonstrated and verifiable experience with authoring regulatory submissions and interacting with reviewers.
• 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.
• Demonstrated computer skills preferably spreadsheets, word processing, database, internet research and other applicable software programs.

Key Benefits

• Attractive Salary package

• Defined Contribution Pension Plan

• Health Insurance Cover

• Life assurance

+ Health & Wellbeing Events Calendar
+ Excellent career progression opportunities
+ Recognition scheme
+ Free Parking
+ Educational assistance
+ Internal training courses
+ Quality Subsidised Canteens & Barista Service
+ Active Sports and Social Club

We are Global

Merit Medical Galway commenced with 22 employees in 1993. Since then Merit has enjoyed year on year revenue growth and developed its workforce to over 900 employees. Headquartered in Salt Lake City, Utah, Merit maintains a diverse, multi-campus manufacturing footprint in Europe, North America, South America, Asia and Australia with a global distribution.

Medtech Company of the Year Winner

Merit Medical Galway are proud winners of the Medtech Company of the Year Award, a prestigious award recognizing those who are exceling in the MedTech industry.

People Development

At Merit Medical Galway almost 60% of all roles are filled by internal employees! We focus on encouraging, believing in and providing a platform for you to progress your career!

Culture

A supportive and collaborative environment make Merit Medical a friendly, enjoyable place to work. We are proud of our energetic and dynamic culture. Diversity & Inclusion is evident here with an 50/50 ratio of male and female employees as well as 30 nationalities onsite! We value every employee as an individual.

To see more on our culture, go to .