Regulatory Affairs Operations Specialist - Korean Speaker at Medtronic-Switzerland

Taguig, National Capital District, Philippines -

Full Time

Start Date

Immediate

Expiry Date

16 Feb, 26

Salary

0.0

Posted On

18 Nov, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Compliance, Document Preparation, Project Management, Database Management, Communication Skills, Data Presentation, Business Writing, Attention to Detail, Technical Document Understanding, MS Office, Regulatory Systems Familiarity, DMAIC Methodology, Medical Device Regulation, Korean Language Skills, English Language Skills, Stakeholder Management

Industry

Medical Equipment Manufacturing

Description

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Responsibilities may include the following and other duties may be assigned: Responsible for coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections. Responsible for compiling all materials required in submissions, license renewal and annual registrations. Recommendations for labeling for regulatory compliance. Monitors and improves tracking / control systems. Prepares, submits, tracks, indexes and archives paper and electronic submissions including information, amendments, annual reports, general correspondence, adverse event reporting, and promotional materials. Keeps abreast of regulatory procedures and changes. May direct interaction with regulatory agencies on defined matters. Recommend strategies for earliest possible approvals. Ensures continuous efficiency and effective process improvement measurements. Required Knowledge and Experience: Bachelor's Degree Required in Medical/ biological science/ Engineering or equivalent field. Minimum of 3 years of job experience in similar role and/or discipline Regulatory or equivalent experience within a device or pharmaceutical company, CRO, or similar organization Language skills: English：Business level in reading, writing and speaking), Korean (TOPIK II, Leve 3 or 4) Relevant exposure to Project Management and Global Stakeholder Management are ideal (and a plus) Attention to details and accuracy Database management and (Familiarity with Regulatory Systems/Tools is a plus) Good communication skills and data presentation Business writing proficiency and standard applications like MS Office, PDF, Sharepoint Good understanding of DMAIC methodology Scientific knowledge, must be able to read and understand technical documents such as test report, raw data, drawing etc. Computer skills (excellent knowledge of MS Office, Excel (V look), Word, computer systems (will use GTS-SAP/Insight/RDR/MAP Agile, etc.) Background in APAC/US/EU Medical Device Regulation is a plus 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. 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). About Medtronic 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. Learn more about our business, mission, and our commitment to diversity here 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. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need. Life-transforming technologies. 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. For updates on job applications, please go to the candidate login page and sign in to check your application status. If you need assistance completing your application please email AskHR@medtronic.com To request removal of your personal information from our systems please email RS.HRCompliance@medtronic.com

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Responsibilities

The Regulatory Affairs Operations Specialist is responsible for coordinating and preparing document packages for regulatory submissions and internal audits. This role also involves monitoring and improving tracking systems and ensuring compliance with regulatory procedures.