associate Regulatory Affairs specialistMedtronic

Careers that Change Lives
Together, we will change healthcare worldwide. Join us in our Mission to alleviate pain, restore health and extend life worldwide. Let's work together to address the universal healthcare needs and improve patients' lives, optimize costs and efficiencies, and expand global access. Together, we can make a real difference in the global disparity in care. By providing quality care at the lowest possible cost, we will succeed as a company, and take the future of healthcare Further, Together.
A Day in the Life
Associate Regulatory Affairs System Specialist
The Associate Regulatory Affairs System Specialist is responsible for the centralization of activities associated with standard regulatory work. In coordination with the Asia Pacific QRA SSC Manager, Project Lead & In-country Regulatory Affairs, develop & maintain relationship with the Regional Regulatory Affairs organization to ensure understanding of the current processes and optimization for SAP-GTS processes.
Key Accountabilities:
GTS License Classification for Extended Material across all countries based upon the inputs in Workflow, Emails or SharePoint requests
Daily Import Block Release for Sales Order, Delivery Notes after coordination with country regulatory specialists and confirming on regulatory classification and import license of products. Adhere to Service Level Agreement of resolution within 24hrs of notification
Daily Block Order/Delivery Report Running every 4hrs and circulate to country regulatory team
Coordinate with cross geography stakeholders from Supply Chain, Regulatory, IT Systems, etc
High Level of Interaction with SAP PG1, PR1 module, IT workflows, Emails, Instant Messaging Tools e.g Microsoft Teams
Work Collaboratively with counterparts in Philippines to meet daily service level agreements
Work with Country Specialists and Project Team to understand processes, regulations and support Project Team to develop Work Instructions for Centralized Operations
Daily Reporting to Project Lead/ Operations Manager on Fulfillment Status, Pending Incidents and Escalations
Work with Project Team and CoE Leads towards Continuous Improvement of processes, workflows etc.
Owns the movement of transactional activities in Center of Excellence including but not limited to: metrics, monthly reporting, status updates, publishing, communications, tracking of key RA activities
Responsible for ensuring effectiveness of implemented harmonized processes through continuous monitoring of compliance.
Support any APAC project & initiatives related to RA Operations including change management initiatives.
Must Have: Minimum Requirements
Bachelor's degree required
0 years of experience required
Nice to Have
Bachelor's degree in science or health related discipline
Minimum 2 years professional experience required or relevant medical device experience with 1year relevant Regulatory Affairs & Quality Assurance.
Experienced 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. (ADA-United States of America)
Additional Information
Posting Date: Jun 2, 2021
Travel: No
Medtronic

Taguig City, Metro Manila
Permanent
Full-time