Job Information
Medtronic Associate Regulatory Operations Specialist in Taguig City, Philippines
Careers That Change Lives
Written in 1960, our Mission dictates that our first and foremost priority is to contribute to human welfare. Over a half-century later, the Mission continues to serve as our ethical framework and inspirational goal for our employees around the world.
A Day in the Life
As the Associate Regulatory Operations Specialist, you will be part of the Regulatory Operations function, covering regulatory activities across Asia Pacific, the Americas and Europe.
Responsibilities may include the following and other duties may be assigned.
Responsible for the preparation, publication, quality control, and delivery of paper and electronic components of regulatory submissions and overall regulatory information (initial, amendments, product life cycle updates)
Ensure that submissions and related processes are produced with electronic publishing tools in compliance with document management standards.
Responsible for activities related to enterprise-wide regulatory management systems, including systems coordination, training others, developing and implementing plans, project support, and providing input to systems designs.
Ensure continuous efficiency and effective process improvement measurements are conducted to evaluate external vendors.
Prepare, submit, track, index and archive: paper and electronic regulatory requirements in different regulatory systems and tools
Must Have: Minimum Requirements
Bachelor’s Degree is required
0 years of experience required
Your Profile
Preferably minimum of 1 year in Regulatory Operations or relevant function, within a medical devices or pharmaceutical company, Contract Research Organization, or similar industry
Bachelor's Degree in Allied Sciences or equivalent field (Pharmacy/Biological Science/Engineering)
Previous hands-on experience with Microsoft Office tools, such as Office and Excel (V-Look Up)
Background on Medical Devices regulations is a plus
Knowledge on scientific and technical documentation, able to read and understand technical concepts such as test report, raw data, drawings, is a plus
Previous hands-on experience with database, regulatory systems, SAP, Calyx, RDR, Power BI is a plus
Able to communicate with different stakeholders, across a high matrix organization
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.
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.