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 Life
The Associate Regulatory Affairs Specialist will support the Regulatory Affairs and Operations activities across Asia Pacific Region. 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 and optimization of the current processes.
Key Accountabilities:
Work with Country Specialists and Project Team to understand processes, regulations and support Project Team to develop Work Instructions for Centralized Operations
Scheduled Reporting to Project Lead/ Operations Manager on Fulfillment Status, Pending Incidents and Escalations
Work with Project Team and SSC Leads towards Continuous Improvement of processes, workflows etc.
Owns the movement of transactional activities in Shared Services Center 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 registration projects across Asia Pacific region in coordination of the Project Lead & In-country ‎Regulatory Affairs. ‎
Maintain internal regulatory systems, database & processes, relating to regulatory
Liaise with stakeholders to any regulatory concerns applicable to the projects.‎
Timely reporting to various stakeholders on the status of ongoing projects ‎Support any APAC project & initiatives related to RA Operations including change management initiatives.
Must Have: Minimum Requirements
Bachelors degree required
0 years of experience required
Your Profile
Bachelor's degree in life science or health-related discipline
At least 3 years of experience in medical device regulatory affairs, technical knowledge on CSDT submission requirements is highly preferred
Proficient in the use of tools/systems - MS Office Suite
Nice to Have
Able to work under pressure and meet tight timeline
Must be Service-Oriented
Eager to learn new things & ready to take up new challenge constantly
Good interpersonal skills - needs to collaborate with various stakeholders and manage their expectations
Good problem-solving skills -Able to solve issues quickly and effectively (i.e. able to quickly identify the underlying issue and implementing a solution)
Must possess accuracy; strong attention to details; ability to prioritize projects and work independently.
Strong English communication, both written and oral
Can work either autonomously or in a team
Experience working in an environment with global objectives.
"Can do" attitude
Welcomes and embraces changes well.
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: May 19, 2022
Travel: No
Medtronic

Taguig City, Metro Manila
Permanent
Full-time