Manager, Regulatory Affairs

4 days ago

East Singapore Emprego SG Full time

**Location**
- Singapore, East**Job Type**
- Permanent**Salary**
- $7,000 - $14,000 Per Month**Date Posted**
- 5 hours agoAdditional Details

**Job ID**
- 99804**Job Views**
- 1Roles & Responsibilities

**Key Job Purpose**:

- Dossier preparation & product registration submission to HSA, leading to timely introduction of new products and responsible for supplemental filings for any changes
- Assisting in data/information gathering & dossier compilation for product registration submission & other related licenses for SAP affiliates & distributors including progress monitoring & follow-ups.
- Provide regulatory support, update, advisory & knowledge sharing to Headquater & Sysmex affiliates and distributors in order to remain in compliance with the government regulatory requirements in Asia Pacific
- Provide leadership & support in managing RA’s team, coaching & provide technical guidance to other SAP RA specialists and to affiliates’ RA

**Responsibilities**:

- Review and edit dossier to comply with regulatory requirements
- Notify and update Health Science Authority (HSA) & any other related agencies of any change of particulars or documents related to product registration
- Ensure changes to the approved products are timely submitted to authorities as required
- Ensure and maintain product approvals and licenses, including dealers etc. where applicable
- Maintain product registration record and product registration database to ensure proper documentation and record filing, including maintain the regulatory database in Sysmex ERP system (MySAP)
- Support in formulating regulatory plan / strategy for timely introduction of new products in AP region
- Provide support to Sysmex affiliates and distributors in new product registration, renewals and amendments
- Maintain the knowledge and awareness of current applicable regulations and standards and industry guidance that impact the company’s compliance.
- Support business partners in new product registration, renewals and amendments
- Support Sales & Marketing and SCM in all regulatory related areas
- Coaching & training of junior RA staff
- Manage adverse event reporting, report adverse event to HSA and authorities in AP countries within the stipulated timeline
- Support in budget planning and company’s Medium Term Planning
- Maintain the knowledge and awareness of current applicable regulations and standards and industry guidance that impact the company’s compliance.
- Coaching & training of other RA staff including affiliate’s RA
- Any other assignments as given by Management from time to time

**Job Requirements**:

- Bachelor Degree in Medical Science or equivalent with 6 years of working experience in regulatory affairs or science/ technical role in healthcare industry (R&D, Clinical or other technical functions) and preferably related to in vitro diagnostics medical device products
- Good understanding of Regulatory framework in AP countries
- Customer focused, team player, responsible, flexibility
- Knowledge of Medical Device Regulation in countries outside APAC, e.g. USA, EU, Japan, etc.
- Travel requirements: Approximately 20%

Tags

manager

regulatory

affairs

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