Associate Regulatory Affairs Systems Specialist

MPI Medtronic Philippines, Inc; Taguig; On-site; PHP 350,000 - 480,000; Full time

Job summary

Medtronic Philippines, Inc is seeking an Associate Regulatory Affairs Systems Specialist to support regulatory submissions and lifecycle activities in Southeast Asia. You will coordinate projects, maintain regulatory systems, and compile submission packages across markets.

The role involves working with Regulatory Affairs teams, operating units, and cross-functional partners to ensure timely and compliant regulatory submissions and lifecycle maintenance.

Qualifications

• Bachelor's degree in regulatory affairs, regulatory operations, healthcare, medical devices, or a related regulated industry.
• Experience managing documentation, records, or data within business systems.
• Experience coordinating multiple projects, deliverables, and deadlines simultaneously.

Responsibilities

• Coordinate regulatory submission activities, timelines, and project deliverables across multiple Southeast Asia markets.
• Create, update, and maintain regulatory applications, events, records, and tasks within regulatory systems.
• Prepare, compile, and organize regulatory dossiers and submission packages for product registrations, renewals, and change submissions.
• Track submission status and provide timely updates on regulatory projects and assigned activities.
• Partner with Business Units and stakeholders to collect, verify, and maintain required regulatory documentation.
• Request, manage, and track regulatory certificates and legal documents, including CFGs, FSCs, and ISO certificates.
• Coordinate translation activities and ensure submission materials meet local requirements.
• Support regulatory administrative activities and maintain accurate regulatory records and documentation.

Skills

Regulatory coordination

Documentation management

Project tracking

Microsoft Office

Education

Bachelor's degree in regulatory affairs, life sciences, or related

Tools

RIM systems

Job description

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

A Day in the Life

The Regulatory Affairs function supports product registration, regulatory maintenance, and compliance activities across Southeast Asia. The team partners with Regulatory Affairs professionals, Operating Units, and cross-functional stakeholders to coordinate submissions, maintain regulatory documentation, and support market access activities that enable products to be commercialized and remain compliant with local regulatory requirements.

The Associate Regulatory Affairs Systems Specialist supports regulatory operations through the management of regulatory systems, submission workflows, documentation tracking, and administrative processes. The role contributes to the timely execution of regulatory activities by ensuring data accuracy, process compliance, and effective coordination across multiple stakeholders.

The Associate Regulatory Affairs Systems Specialist supports regulatory submission and registration activities across Southeast Asia by coordinating regulatory projects, maintaining regulatory systems, preparing submission documentation, tracking deliverables, and supporting compliance with country-specific regulatory requirements.

This role collaborates with Regulatory Affairs teams, Operating Units, and cross-functional partners to help ensure timely and accurate regulatory submissions and product lifecycle maintenance activities.

Primary Responsibilities

• Coordinate regulatory submission activities, timelines, and project deliverables across multiple Southeast Asia markets.
• Create, update, and maintain regulatory applications, events, records, and tasks within regulatory systems.
• Prepare, compile, and organize regulatory dossiers and submission packages for product registrations, renewals, and change submissions.
• Track submission status and provide timely updates on regulatory projects and assigned activities.
• Partner with Business Units and stakeholders to collect, verify, and maintain required regulatory documentation.
• Request, manage, and track regulatory certificates and legal documents, including Certificates to Foreign Governments (CFGs), Free Sales Certificates (FSCs), and International Organization for Standardization (ISO) certificates.
• Coordinate translation activities and ensure required submission materials are available and compliant with local requirements.
• Support regulatory administrative activities and maintain accurate regulatory records and documentation.

Required Qualifications

• Bachelor's degree with 1+ years of experience in Regulatory Affairs, Regulatory Operations, Healthcare, Medical Devices, Life Sciences, or a related regulated industry.
• Experience managing documentation, records, or data within business systems.
• Experience coordinating multiple projects, deliverables, and deadlines simultaneously.
• Proficiency in Microsoft Excel, Word, and PowerPoint.
• Written and verbal communication skills supporting cross-functional stakeholder collaboration.

Preferred Qualifications

• Experience supporting medical device, pharmaceutical, biotechnology, or healthcare regulatory processes.
• Knowledge of medical device registration, renewal, and product change submission requirements.
• Experience with Regulatory Information Management (RIM) systems or document management platforms.
• Experience preparing technical documentation, regulatory dossiers, or submission packages.
• Experience supporting regional or multinational regulatory operations within Southeast Asia.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

Recruitment Fraud Alert

We are aware of phishing scams targeting job seekers. Please keep the following in mind: Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses. Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate. If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments. If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at [e-mail].

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. We change lives. Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. We build extraordinary solutions as one team. With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough. This life-changing career is yours to engineer. By bringing your ambitious ideas, unique perspective and contributions, you will… Build a better future, amplifying your impact on the causes that matter to you and the world Grow a career reflective of your passion and abilities Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning These commitments set our team apart from the rest: Experiences that put people first. Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life.

No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms. Better outcomes for our world. Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls. Insight-driven care. Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care 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. For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here.

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