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Lead, Regulatory Affairs
4 weeks ago
At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.
**Position Summary**:
Reporting to the Director, RA/QA APAC, within the Regulatory and Compliance team, the incumbent is responsible for supporting the development and administration of STERIS’s global regulatory policy positions across product lines of the STERIS businesses by preparing international regulatory submissions for STERIS (and its affiliates) product approvals and the works to meet Malaysia and other Southeast Asia countries post market surveillance requirements. The incumbent will also provide support for plans to achieve identified corporate regulatory policy objectives. Responsible for keeping abreast of and providing regular reporting to key business leaders on key regulatory developments that impact customers, or STERIS’s business directly.
**Duties**:
1. Identify regulatory and post market requirements for new products or product enhancements early in the product development cycle. Collect regulatory and post market requirements for Malaysia and other key markets in Southeast Asia.
2. Gather information to support regulatory submission and related compliance activities. Use this information to prepare regulatory submissions in a complete, thorough format to support STERIS product claims. Coordinate compulsory test in the region when there is the need.
3. Review product revision requests to assure compliance with regulatory and post market requirements. Assess new product launch requirements and provide the regulatory information according to the needs.
4. Work on product teams to develop regulatory strategy based on regulatory and post market requirements.
5. Review and approve labelling and marketing literature, as needed.
6. Support Director, RAQA APAC and other Regulatory Affairs staff with all regulatory and compliance matters. Conduct timely activities of supervisor assigned.
7. Work with direct supervisor and senior internal stakeholders to identify key initiatives, which may be affected by present or emerging policies. As part of this, develop and recommend government affairs policy positions to upper management.
8. Lead the Recall and Adverse Event reporting in Malaysia and other key markets in Southeast Asia. Work with Compliance team and follow the regulation for Recall and Adverse Event reporting.
9. Archive and maintain all paper and electronic submission documents properly.
10. Protect company confidential information by properly storing, retrieving, and disseminating such information only to those authorised.
12. Work with Director, RAQA APAC and cross-functionally with local team to assure the ISO 13485 and/or GDPMDS quality system operates in compliance with applicable regulatory standards, including participation in internal and external audits / inspections as well as supplier audits / inspections.
13. Development / maintenance of local quality system processes, GDPMDS, ISO 13485 and/or customer audit facilitation and document control.
14. Utilise CAPA (Corrective Action / Preventative Action) system, including issuance of CAPAs, tracking of open CAPAs, and reporting on CAPA effectiveness.
15. Gather and trend quality data for Quality Management Reviews.
16. Supplier management.
**Duties - cont'd**:
**Education Degree**:
- Associate's Degree**Required Experience**:
1. Minimum associate degree with 4 - 6 years solid experience with good track record in SEA Regulatory Affairs professions.
2. Familiar with the standards and regulations of SEA markets. Work in Medical Device related company and have the experience for Medical Device registration.
3. Fluent English in speaking and writing. English communication is necessary required.
4. Positive working attitude and responsive.
5. Meticulous, precise, and analytical.
6. A self-starter and able to work independently with minimum supervision.
7. Good organisational, time management, project management, and problem-solving skills.
8. Excellent communication skills and a good team player.
9. Proficiency in English.
10. Able to work under time pressure to meet deadlines and accept need to work additional reasonable working hours to join in conference calls as required.
STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare, life sciences and dental products and services. STERIS is a $5 billion, publicly traded (NYSE: STE) company with approximately 17,000 associates and Customers in more than 100 countries.
STERIS strives to be an Equal Opportunity Employer.
