Associate Regulatory Operations Specialist (Japanese Bilingual)

Medtronic; United States; Remote; USD 60,000 - 85,000; Full time

Job summary

At a leading healthcare technology company, the role focuses on regulatory submissions and management within the medical device sector. Candidates should possess strong scientific knowledge and familiarity with regulatory systems, ensuring compliance and efficiency in processes. This position offers competitive compensation and a supportive benefits package, aligning with the company's commitment to employee welfare.

Benefits

Competitive Salary

Flexible Benefits Package

Career Development Opportunities

Qualifications

• Bachelor's degree required in medical/biological science/engineering.
• Minimum 1 year experience in similar role.
• Background in medical device regulation preferred.

Responsibilities

• Responsible for preparation and quality control of regulatory submissions.
• Coordinates activities related to regulatory management systems.
• Prepares and tracks electronic regulatory requirements.

Skills

Database Management

Regulatory Systems Management

Scientific Knowledge

Communication

Education

Bachelor's Degree in Allied Sciences

Tools

MS Office

Excel

SAP

PowerApps

PowerBI

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

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)

• 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.

• Ensures continuous efficiency and effective process improvement measurements are conducted to evaluate external vendors.

• Prepares, submits, tracks, indexes and archives paper and electronic regulatory requirements in different regulatory systems and tools

Required Knowledge and Experience

• Bachelor's Degree Required in Allied Sciences (Medical/ biological science/ Engineering or equivalent field)

• Minimum of 1 year job experience in similar and/or related role

• Regulatory or equivalent experience within medical device or pharmaceutical company, CRO, or similar organization

• Background in Medical Device Regulation is a plus

• Database and Regulatory Systems Management

• 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, affinity to computer systems (will use SAP, Calyx, RDR, etc.) and data management tools (PowerApps, PowerBI - highly preferred)

• Good written and verbal English communication skills

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.

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