Regulatory Affairs Specialist II

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

DUTIES & RESPONSIBILITIES

• Assist with determining 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 international submissions or regulatory rationales.  
• Identifies guidance documents, international standards, Consensus Standards and assists teams with their interpretation.
• Prepares regulatory submissions to the Ministries of Health wherever required.
• Interacts with various levels of management, external agencies and companies.
• Assist with developing, maintaining and analysing department systems and provides training when needed.
• Participates in and assists with the preparation of Notified Body Audits and other governmental inspections as directed.
• Performs other related duties and tasks, as required.

SUMMARY OF MINIMUM QUALIFICATIONS

• Education and/or experience equivalent to a Bachelor's Degree in the biological, physical, engineering or health science disciplines and four years of related experience. 
• Strong knowledge of regulations, the Medical Devices Directive (93/42/EEC, as amended), Medical Device regulation (2017/745), MEA region and ISO 13485 Quality System Standards.
• Supervisory skills are preferred.
• 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.

We are Global

Founded in 1987, Merit Medical Systems, Inc. is a leading manufacturer and marketer of proprietary disposable medical devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care and endoscopy. Merit serves client hospitals worldwide with an international sales force and clinical support team totalling in excess of 500 individuals. Merit employs approximately 6,300 people worldwide.

Merit Medical EMEA currently has over 300 employees, spread over more than 20 countries in the EMEA region.

Merit Maastricht (The Netherlands) is the European Headquarters and Distribution Center of Excellence. Much of Merit Medical’s world-class customer service happens here along with our excellent physician training courses. More than 100 employees work at this growing Merit campus and enjoy many benefits, such as flexible working hours and competitive salaries as well as learning opportunities and internships.

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 a 50/50 ratio of male and female employees and more than 30 nationalities. We value every employee as an individual.

To see more on our culture, go to www.merit.com/careers.