Regulatory Operations Specialist

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 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.

• Handle the preparation, publication, quality control, and delivery of paper and electronic components of all submissions, including initial large marketing authorization applications and electronic common technical documents (e-CTD).
• Ensure that submissions are produced with electronic publishing tools, in compliance with document management standards.
• Handle activities related to enterprise-wide regulatory management systems, including systems coordination, training others, developing and implementing plans, and providing input to systems designs.
• Ensure that continuous efficiency and effective process improvement measurements are conducted to evaluate external vendors.
• Prepare, submit, track, and archive paper and electronic submissions including information, amendments, annual reports, general correspondence, adverse event reporting, and promotional materials.

Must Have: Minimum Requirements:

• Bachelor’s Degree is required (preferably in Allied Sciences or similar disciplines)
Minimum of 2 years of relevant experience, or advanced degree with 0 years of experience

Your Profile

• Minimum 2 – 3 years of regulatory operations experience within a pharmaceutical or medical devices company, Contact Research Organization, or similar industry
• Knowledgeable on scientific data, can read and understand technical documentation, such as test report, raw data, drawing, etc.
• Knowledge on SAP/Insight/ /Ariba/Polaris, database management tools, Regulatory Systems tools, and Microsoft Office applications, with advanced experience on Microsoft Excel
• Ability to communicate and present data effectively
• Knowledge on Asia Pacific, US or European medical devices regulations is a plus
Experience interacting with Regional and Global stakeholders is a plus

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 companys 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.