Manager, Regulatory Affairs

Manager, Regulatory Affairs page is loaded

Manager, Regulatory Affairs

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

Manages and performs global regulatory affairs activities for the assigned portfolio and/or regions.

RESPONSIBILITIES

• Ensure that new and existing products meet regulatory requirements within the assigned region.

• Ensures that the department is appropriately resourced and organised.

• Manages the day-to-day activities of the regulatory affairs department and ensures that the department is appropriately resourced and organised.

• Determines regulatory pathways for multiple projects including product classification and type of regulatory submission or rationale required for the assigned region.

• Participates on various teams to define regulatory requirements for international submissions, Technical Files or regulatory rationales.

• Leads the Advocacy process for the region, identifies applicable (upcoming) requirements and regulations, guidance documents, and provides Merit guidance on its scope, impact, and applicable timelines.

• Prepares and oversees regulatory submissions to registration agencies, regulatory authorities, and distributors.

• Provides information regarding country specific technical and clinical requirements for international submissions.

• Interacts with various levels of management, external agencies, and companies.

• On request, analyses and makes recommendations regarding complaints received by Merit Medical and whether they are reportable incidences in the assigned regions.

• Acts as the recall coordinator for the assigned region.

• Develops, maintains, and analyses department systems and provides guidance and training where needed.

• Remains current on developing regulations and revises systems and documentation as necessary.

• Organizes and/or participates in and assists governmental audits and inspections as needed.

• Develops internal documentation as requested.

• Executes special assignments as required.

• Manages the assigned budgets as needed.

• Leads and contributes to continuous improvement initiatives.

• Leads regional TMS process and its implementation of findings.

• Performs other related duties and tasks, as required.

EDUCATION /QUALIFICATIONS/COMPETENCIES

• Education and experience equivalent to a minimum of a Bachelor’s degree in the biological, physical, engineering or material science disciplines.

• A minimum of seven years regulatory experience of which a minimum of five years in a supervisory position.

• Demonstrated knowledge of assigned regional and global regulatory requirements.

• Strong interpersonal skills and the ability to communicate well – verbally and in writing – with others.

• Strong knowledge on International medical device regulations

• Strong experience with product lifecycle processes

• Self-motivated, proactive, strong attention to detail and excellent time management skills.

• Excellent analytical and problem-solving skills.

• Demonstrated excellence in submission writing and preparation.

• Demonstrated competency with office 365 software applications.

• Excellent leadership skills and the ability to work well with people at all levels of the organization.

• Have excellent mentoring capabilities and assuring team is taken care of.

• Lead the team by example by organisational values (Customer First, Achieving Excellence, Developing People, Flexibility and Integrity) in carrying out of all assigned responsibilities/tasks.

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 .

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 a domestic and international sales force and clinical support team totaling in excess of 500 individuals. Merit employs approximately 6,000 people worldwide with facilities in South Jordan, Utah; Pearland, Texas; Richmond, Virginia; Aliso Viejo, California; Maastricht and Venlo, The Netherlands; Paris, France; Galway, Ireland; Beijing, China; Tijuana, Mexico; Joinville, Brazil; Ontario, Canada; Melbourne, Australia; Tokyo, Japan; Reading, United Kingdom; Johannesburg, South Africa; and Singapore.