RAQA Executive

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.

JOB FUNCTION

 

1.     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.

 

 

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

·      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.

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.

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