Regulatory Affairs Specialist, SEA

Found in: Talent SG C2 - 6 days ago


Singapur, Singapore Arthrex Full time

Description

Benefits & Highlights:

Work Style: Hybrid/Flex Location: Buona Vista Great employee benefit Weekly office lunches Reporting Line: Regulatory Manager, APAC

About the Role: -

Responsible for the daily operations of regulatory affairs and assures regulatory submissions meet local and regional compliance requirements. Staying abreast with regulatory compliance requirements and changes affecting company operations and products. Generates and manages submission documents for new products or changes to existing regulatory submissions.

Change Assessments (RA Compliance and Document Control)

Supporting the review of change assessments to provide regulatory impact and associated information to the global change management team.Supporting the preparation of submission dossiers for reportable changes.Supporting the management and maintenance of change information.

Regulatory Affairs (RA) Submissions and Applications

Writing, preparing, submitting regulatory documents for the South-East Asia (SEA) market (Arthrex distributor and subsidiary)Communicating with regulators on submission projectsPrioritising and organising multiples projects with competing prioritiesParticipating in regulatory affairs planning for SEA marketsProviding support in APAC level projects as and when neededReviewing product labelling and Directions for Use (DFU), if any translation is required

Ongoing Education and Training

Proactively attending seminars, lectures and academic conferences to continuously develop skills and to collect and share insights

Regulatory Intelligence

Keeping abreast with the latest regulatory updates within SEA relating to Arthrex products and ensuring Arthrex as a company is aware, ready and able to comply with the necessary changesProviding input to change management projects for global regulatory change assessmentsParticipating and providing support in cross-functional collaboration on new product and country launches

Product Recall and Complaint Support

Supporting product safety alert activities and field actionsAssisting in activities relating to post market surveillance ( Complaints, Performance Evaluation Reporting (PER), Adverse Event Reporting (AER), and/or liaising with Regulatory bodies in assigned countries)Participating in both internal and external quality system audits
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