Associate Regulatory Operations Specialist - Japanese Speaker

Medtronic plc; Taguig; On-site; PHP 1,803,968 - 3,006,614; Full time

Benefits offered by this job

Flexible benefits package

Short-term incentive (Medtronic Incentive Plan)

Job summary

Medtronic plc in Taguig, Philippines is looking for a Regulatory Specialist responsible for the preparation, publication, and quality control of regulatory submissions. The candidate must have a Bachelor's degree in a relevant field, Japanese language skills at JLPT N3 level, and at least one year of relevant experience. The role involves evaluating vendors and ensuring compliance with regulatory guidelines. Benefits include a competitive salary and flexible benefits package, aimed at supporting employees in their career and life stages.

Qualifications

• Bachelor's Degree in Medical/Biological Science/Engineering required.
• Minimum of 1 year experience in a similar role.
• Japanese language skills at JLPT N3 level or equivalent.

Responsibilities

• Prepare, publish, and control quality of regulatory submissions.
• Coordinate with regulatory management systems and provide training.
• Improve processes and evaluate external vendors.

Skills

Attention to details

Database management

Good communication skills

Scientific knowledge

Computer skills

Education

Bachelor's Degree in Medical/Biological Science/Engineering

Tools

MS Office

Excel (V look)

GTS/Insight/RDR/Ariba/Polaris/Readsoft

Job 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**Job Description 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 all submissions including initial large marketing authorization applications and electronic common technical documents (e-CTD).· Submissions 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, and providing input to systems designs.· Ensures continuous efficiency and effective process improvement measurements are conducted to evaluate external vendors.· Prepares, submits, tracks, indexes and archives paper and electronic submissions including information, amendments, annual reports, general correspondence, adverse event reporting, and promotional materials.**SPECIALIST CAREER STREAM:**Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects – from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.**DIFFERENTIATING FACTORS****Autonomy:**Entry-level individual contributor on a project or work team. Works with close supervision.**Organizational Impact:**Delivers work of limited scope, typically smaller, less complex projects or related activities.**Innovation and Complexity:**Identifies, defines and addresses problems that are not immediately evident but typically not difficult or complex. Makes minor changes in systems and processes to solve problems .**Communication and Influence:**Communicates primarily with internal contacts within immediate group. Contacts others to gather, confirm and convey information.**Leadership and Talent Management:**N / A – job at this level is focused on self-development. **Required Knowledge and Experience:*** Bachelor's Degree Required in Medical/ biological science/ Engineering or equivalent field.* **Language skills** Japanese/English Communication skills, (Japanese: able to read and write words in Japanese (JLPT N3 level or up N1～N5:認定の目安 | 日本語能力試験JLPT, English：Business level in reading, writing and speaking)* Minimum of 1 year job experience in similar role* Attention to details and accuracy* Database management* Good communication skills* Scientific knowledge, must be able to read and understand the technical document such as test report, raw data, drawing etc.* Computer skills (excellent knowledge of MS Office, Excel (V look), Word , computer systems (will use GTS/Insight/RDR/Ariba/Polaris/Readsoft）* Regulatory or equivalent experience within a device or pharmaceutical company, CRO, or similar organization* Background in Japanese 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* **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 learningThese 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 careIt 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 settingis 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 .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 [e-mail] request removal of your personal information from our systems please email [e-mail]