jobapplier

RAQA Executive

Merit

About Merit

900a-530p M-W F 700a-330p TH {8} 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.

Responsibilities

  • Pre-market Activities · Manage medical device registration, renewal, and license maintenance activities with the Indonesian Ministry of Health. · 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. · 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, FCA, recall, adverse event reporting) in accordance with the local authorities’ regulatory requirement. · Support internal and external audits and inspections.
  • Regulatory Intelligence · Keep abreast with the latest updates 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.
  • 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 Company's vision, objectives and shared values. · Develop effective working relationship with Regional regulatory team, Platform regulatory team, cross-functional teams 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.
  • All levels of cross-functional associates and cross-site regulatory counterparts.
  • Regulatory Affairs Representatives, distributors, relevant Regulatory Bodies / Agency and Notified Bodies.

Requirements

  • 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.

Preferred

  • Degree holder · Pharmacist is a plus Relevant Experience: · Preferably 4 to 6 years of relevant experience in medical device, with minimum 4 years relevant experience in regulatory affairs in medical devices.

Work Schedule

JOB FUNCTION 1.

Others

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