Regulatory Affair Specialist (1 year contract)

The Regulatory Affairs Specialist (1 year contract) is responsible for all activities related to product registration, regulatory submissions, actively contributing to the regulatory compliance of medical device products under their responsibility. The position is also responsible for ensuring compliance to the company SOP and ensuring that the company’s legal compliance is in line with relevant regulations.
Primary duties and responsibilities:
- Obtain and manage permits and licenses for the importation of products from different Local Government Agencies.
- Assess regulatory and product changes / updates. Manages the maintenance of data for timely tracking of status of all Licenses and registrations (pending and approved), including post-approval changes.
- Proactively communicate and collaborate with different business units, regional and global and address the potential business impacts of any emerging, revision or new regulation applied to Vietnam.
- Provide accurate regulatory information and product registration status to the organization.
- Prepare, submit, coordinate and follow up on product registration in Vietnam for all Medical Device based.
- Coordinate with related functional teams on Post-Marketing surveillances activities of medical product: Product complaints, Field Safety Corrective Actions, Adverse event reporting.
- Act as an accountable Regulatory Affairs person to provide advice and consultation to local / regional / global teams on Vietnam regulation.
- Review and submit advertisement materials of related BUs if appropriate.
- Promote awareness and train the local team to maintain compliance.
- Prepare, order and maintain documents for tender. Coordinate to provide documents for customer concerns.
Main tasks include but are not limited to:
- Liaise with HQ and regional partners to ensure appropriate documents required for registration of products are available on time. Ensure timely preparation, submission and follow up of registration applications to secure timely approvals.
- Prepare, submit, and monitor product registrations with local authorities for medical devices.
- Liaise with relevant sales division on sales and marketing strategy to ensure timely approval of registrations to meet new product launches.
- Advise and train stakeholders about medical device management regulation.
- Do the assessment and advise HQ about medical device management regulation (if required).
- Provide regulatory information for tenders, price disclosing, and import custom clearance purpose.
- Promote regulatory and quality awareness throughout the organization.
- Report to local authorities in a timely manner on post-market surveillance activities such as Adverse Event Reporting and Field Safety Corrective Action (FSCA) (If any).
- Maintain and update valid required documentation both in hardcopy/softcopy in shared drive/system for registration, tender, and other business purposes.
- In charge of RA auditing (if any).

Salary and Bonus scheme in accordance with company policy
,#Health Insurance policy for employees & dependents in accordance with the company
,#Travel and training in oversea (SEA, Germany...)

Communication, Interpersonal Skills, Microsoft Office, Regulatory Affairs, Medical Device Regulations