Regulatory Affairs Specialist

2 weeks ago

Singapore MERIT MEDICAL SINGAPORE PTE. LTD. Full time

**PURPOSE OF JOB**

Subject matter expert in determining the current regulatory requirements and strategies for Merit Medical Singapore design control projects. Prepare documents and /or submission required to obtain clearance or approval from government agencies for commercial distribution of Merit’s Medical Devices. Key government agencies with direct responsibilities include US FDA, Health Canada, Europe and Singapore. A supporting role to the Regulatory Affairs associates in the local countries to obtain the product approvals. Communicate to the local authority, HSA, for any adverse event reporting and manage any product recalls for Singapore.

**JOB FUNCTION**
- 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.
- Prepare CSTD submission package to Singapore Health Science Authority. Maintain the dealer licenses and product licenses/clearance for importation and sales
- Support the international regulatory specialist within the global regulatory affairs department with product registration in accordance with their local regulatory requirements.
- Maintain current knowledge and stay abreast with the Federal USA polices/guidance, Canadian regulations, EU medical device regulation and Singapore HSA regulation pertaining to legal distribution of medical products. Implements and drives any new medical device requirement within the quality system environment.
- Communicate the Medical Device Reporting and Vigilance Reporting in accordance with the local authorities’ regulatory requirement. Collaborate with the corporate office to conduct any local field safety corrective actions or product recalls.
- 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.

**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 minimum 2 years relevant experience in regulatory affairs. Fresh graduate may be considered.
- 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.

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