associate Regulatory Affairs specialistMedtronic

Job Description:
Careers that Change Lives
We're a mission-driven leader in medical technology and solutions with a legacy of integrity and innovation. Join our team in (Clinical Affairs, Regulatory Affairs, Medical Affairs) and help shape policies that change lives.
Work with us to incentivize better patient care, and partner across the industry to make healthcare more affordable and accessible. Be a part of a community of experts committed to ensuring quality, affordable healthcare worldwide.
A Day in the Life
Responsibilities may include the following and other duties may be assigned.
Execute submission strategy.
Performs coordination and preparation of document packages for regulatory submissions for Global Region
Leads or compiles all materials required in submissions, license renewal and annual registrations.
Monitors and improves tracking / control systems.
Keeps abreast of regulatory procedures and changes.
Recommends strategies for earliest possible approvals of clinical trials applications.
Provide on-time status about projects under their scope and all applicable regulatory activities assigned.
Must Have:
Bachelor's Degree required.
0 years of experience required.
Your Profile
Bachelor's degree in Pharmaceutical Sciences, Industrial Engineering, Biomedical Engineering, or field related experience is an advantage.
At least 1-year regulatory experience in medical devices is highly appreciated.
High proficiency in Microsoft tools
Excellent communication skills
Databases management, document interpretation, queries, and workflow skills.
Strategic thinking, analytical and problem-solving skills, decision making skills.
About Medtronic Philippines
Established in 2015, Medtronic Philippines is committed to best-in-class patient and customer experience by delivering capacity, scalability, sustainable productivity levels and innovative solutions to our stakeholders, patients, and customers.
The establishment has over 450 employees on-site with more than 60% being female employees.
What We Offer
We recognize the personal worth of employees by providing an employment framework that allows personal satisfaction in work accomplished, security, advancement opportunity, and means to share in the company's success. We believe in rewarding our staff with a complete package of benefits designed to support them at every career and life stage. As a result, our employees have access to the following benefits, to name a few:
Our global well-being program supports your physical, emotional, social, and financial well-being.
Medtronic Employee Assistance Program offers confidential support and resources to build and enhance employee and organizational resilience, productivity, teamwork, and psychologically healthy workplaces.
Various insurance benefits include Inpatient and Outpatient Medical Insurance, Life, Disability and Accident Insurance.
We have generous employee referral programs, employees stock purchase plan, leave benefits, and more!
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.
Medtronic

Taguig City, Metro Manila
Permanent
Full-time