Regulatory Affairs Specialist - 28446BR - EI in Singapore at Stryker Corporation

Date Posted: 4/9/2018

Job Snapshot

Job Description

1) Manage all government product registrations/change notifications/re-registrations/licence renewals/input requests-questions and other related actions in ASEAN and manufacturing divisions to ensure timely initiation and closures per internal and regulatory deadlines to be in line with product launch/business plans. Support customers/dealers/partners in ASEAN likewise where Stryker entity is not the product holder, and ensure their timely registration/licence renewal success.
2) Maintain record, tracking, master, monthly reporting and documents related.
3) Supporting Post Market Activity and ensuring timely and correct reporting/ follow up to authority.
4) Review corporate RA procedures/regulatory requirements and assess gaps between existing Quality Management System (QMS) in place and propose drafts to supervisor to meet corporate and latest/prevailing regulatory requirements.
5) Provide timely and regular updates to management on changes in regulations related to pre-market/registration requirements. Identify any gaps and risks early, and propose strategies to supervisor and management by regularly attending training/briefing sessions conducted by government agencies or active participation in local industry workgroups.
6) Manage iROS/any other related system updates for ASEAN countries.
7) Participate in local/industry, regional/international, corporate initiatives and project groups related to pre-market activities.
8) Support any project related to QARA and continuous process improvement.
9) Any other task relevant to QA RA.
Advocacy Responsibilities and functions (if applicable*) :
10) Participate in technical committees and trade associations during discussions and public consultations on existing or proposed regulations *
11) Monitor the necessary procedures with the regulatory authorities and Ministries of Health of different countries to obtain regulatory approvals.
12) Prepare and submit answers to the health authority on registration dossiers in process.
13) Prepare, submit and follow up consultations on applicable regulations on company products and processes.
14) Communicate and keep organization and stakeholders informed about possible changes to health regulation and its implications in region's countries.
15) Maintain and develop a Regulatory intelligence database and be capable to analyze the information available.

Job Requirements

• Minimum bachelor’s degree in pharmacy, biomedical sciences or related
• Minimum 1- 2 year experience in ASEAN countries
• Prior experience in QMS management and certified internal auditor for ISO 13485 (preferred)
• Be the poisons licence holder in the local country for Stryker if a registered pharmacist & a requirement by local authorities.
• Health regulation in force for medical devices.
• Possess cross-cultural sensitivity
• Excellent communicator
• Able to work cross-functionally with different stakeholders in the company to drive desired outcomes
• Independent and self-driven, has initiative, achiever and Timely, Compliant
• Project Management, effective presentations and negotiation skill
• Regulatory intelligence

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