associate Regulatory Affairs specialistMedtronic

Careers that Change Lives
Bold thinking. Bolder actions. We are Medtronic.
Quality Assurance & Regulatory Affairs Shared Service Center team aims to be a strategic and trusted partner in Asia Pacific Region. Providing value-add services, drive reengineering of process, resource optimization and cost savings, we aspire excellence to drive solutions for centralized processes, integrate these values into what we do therefore enabling our stakeholders to achieve their goals with a balance of quality, productivity, cost, and effective service.
A Day in the Life
The Associate Regulatory Affairs Specialist will be responsible for the management & maintenance of IT infrastructure and tools that facilitate APAC regulatory submissions and data sharing. Will be involved in the development and execution of an operational support strategy that unburdens Regulatory Affairs personnel from common maintenance activities. The role will help build registration strategy with local Regulatory Affairs team and developing standard scorecards for reporting on APAC /Country Regional metrics.
Responsibilities:
Support (or assist in) management of regulatory tools and database across Asia Pacific region e.g. publishing, eIFU maintenance in Medtronic site
Support registration projects across Asia Pacific region
Support the product registration process including Insight request, review & compilation of the registration in coordination of the Project Lead & In-country Regulatory Affairs.
Maintain internal regulatory systems, database & processes, relating to regulatory & quality such as Insight, SAP, GTS
Liaise with global regulatory affairs on requested documents
Timely reporting to various stakeholders on the status of ongoing projects
Other duties assigned by the Asia Pacific QRA - Shared Services Center Manager
Must Have: Minimum Requirements
Bachelors degree required
0 years of experience required
Nice to Have
Bachelor's degree in science of health-related discipline
Your Profile
Minimum 2-year regulatory experience
Background in STED, CSDT
Background in IT systems, database and business processes to support training
About Medtronic
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.
Physical Job Requirements
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
Additional Information
Posting Date: Oct 14, 2022
Travel: No
Medtronic

Taguig City, Metro Manila
Permanent
Full-time