ABOUT THE COMPANY
Founded in 1987, Merit Medical Systems, Inc. (NASDAQ: MMSI) is engaged in the development, manufacture and distribution 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 300 individuals. Merit employs approximately 6,000 people worldwide with facilities in South Jordan, Utah; Pearland, Texas; Richmond, Virginia; Malvern, Pennsylvania; Rockland, Massachusetts; Aliso Viejo, California; Maastricht and Venlo, The Netherlands; Paris, France; Galway, Ireland; Beijing, China; Tijuana, Mexico; Joinville, Brazil; Markham, Ontario, Canada; Melbourne, Australia; Tokyo, Japan; Reading, United Kingdom; Johannesburg, South Africa; and Singapore.
PURPOSE OF JOB
Subject matter expert in the current regulatory requirements and strategies for the South-east Asia (SEA) countries, namely Singapore, Malaysia, Indonesia, Thailand and Vietnam.
Responsible for the daily operations of regulatory affairs and ensuring regulatory compliance within SEA countries stated above. Obtaining the regulatory approvals from government agencies for commercial distribution of Merit’s Medical Devices. Conducting product change assessment and obtaining the approval for the reportable changes.
Handling product complaints and managing adverse event reporting and any product recalls.
JOB FUNCTION
1. Pre-market Activities
· Provide independent regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new or changed product launches.
· Strategizing the regulatory plans, submission, and approval of medical device applications for all new products and life cycle management in SEA.
· Writing and maintaining the regulatory submission dossier according to the local regulatory requirement. Submitting and obtaining the approval through quality responses and effective lobbying of the local regulatory agencies.
· Reviewing product change assessment and providing the regulatory impact with its associate information to the change management team. Preparing the submission dossiers for the reportable changes.
· Prioritizing and organizing multiple projects with competing priorities.
· Maintain product registration record and product registration database to ensure proper documentation and record filing for business partner countries and global team.
2. Post-Market Activities
· Manage post-market surveillance activities (complaints handling, adverse event reporting) in accordance with the local authorities’ regulatory requirement.
· Support local Field Safety Corrective Actions and/or Product Recall.
· Monitor and report adverse events and/or Field Safety Corrective Actions to the relevant regulatory authorities within the SEA.
3. Regulatory Intelligence
· Maintain current knowledge and keep abreast with the latest updates within the SEA relating to Merit Medical products. Ensuring the company is aware and able response timely to comply with the necessary changes.
· Implements and drives any new medical device requirement within the quality system environment.
4. Partnering with Stakeholders
· Leads and/or works within department and/or cross functional teams in achieving regulatory affairs initiatives to support departmental goals in alignment to Plant's vision, objectives and shared values.
· Develop effective working relationship with Global Regulatory Lead, Site Specialists, cross-functional teams, regulatory consultants and business partners countries.
· Provide regulatory advisory to commercial team to align with product launch strategies and assist in regulatory documents submission for hospital or tender requirements.
· Manage Quality Complaints and coordinate and monitor the pre-market and post-market activities conducted by distributors.
INTERACTION
Internal parties:
· All levels of cross-functional associates and cross-site regulatory counterparts.
External parties:
· Regulatory Affairs Representatives, distributors, relevant Regulatory Bodies / Agency and Notified Bodies.
JOB SPECIFICATIONS
Education:
· Degree holder
· Diploma/Advance Diploma
Relevant Experience:
· Preferably 5 years of relevant experience in medical device, with minimum 3 years relevant experience in regulatory affairs in medical devices.
Others:
· Computer literate, preferably in MS office.
· Ability to lead, supervise and work in a team environment.
· Strong written and oral communication, and technical writing skills
· Good interpersonal skills.
· Strong critical thinking coupled with sound decision making skills in bringing successful resolution to high-impact, complex, and/or cross-functional problems
