Regulatory Affairs & Quality Assurance Specialist

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.

Summary

Reporting to the Lead, Regulatory Affairs & Quality Assurance SEA, you will be 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 Singapore and other Southeast Asia countries post-market surveillance requirements. You will also provide support for plans to achieve identified corporate regulatory policy objectives. You are keeping abreast of and providing regular reporting to key business leaders on key regulatory developments that impact customers, or STERIS’s business directly.

What You Will Do

• 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 Singapore and other key markets in Southeast Asia.
• 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 tests in the region when there is the need.
• 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.
• Work with product teams to develop regulatory strategy based on regulatory and post-market requirements.
• Review and approve labeling and marketing literature, as needed.
• Support supervisor, management and other Regulatory Affairs staff with all regulatory and compliance matters.
• Work with direct supervisor and senior internal stakeholders to identify key initiatives, which may be affected by present or emerging policies. Develop and recommend government affairs policy positions to upper management.
• Support QA on the Recall and Adverse Event reporting in Singapore and other key markets in Southeast Asia, perform Recall and Adverse Event reporting.
• Archive and maintain all paper and electronic submission documents properly.
• Protect company confidential information by properly storing, retrieving, and disseminating such information only to those authorized.
• Apply for special access and/or other permits related to product/site, as needed.
• Support QA on local quality system processes, GDPMDS, internal and external audit.
• Support on NEA Packaging Reporting, SPF Hazardous License, as needed.
• Conduct monthly update meetings with all relevant stakeholders, actively participate in RA/QA team activities.
• Monitor proposed and newly implemented regulations, assess impact to STERIS; develop and implement regulatory strategies to comply with regulations and minimize any negative impact to STERIS Business.
• Provide proactive and strategic guidance regarding pending regulations / government legislative actions and changes in the regulatory environment to the business units. Develop strong relationships with government and industry as well as notified bodies to ensure clear and effective communications and sources of information impacting STERIS.

The Experience, Skills and Abilities Needed

• 3 - 5 years solid experience with good track record in SEA Regulatory Affairs professions.
• Well-versed in the standards and regulations of SEA markets.
• Experience in Medical Device registration.
• A self-starter and able to work independently with minimum supervision.
• Good organizational, time management, project management, and problem-solving skills.
• Excellent communication skills and a good team player.
• Able to work under time pressure to meet deadlines and flexible to work additional reasonable hours to join in conference calls as required.