Associate Regulatory Operations Specialist- 3

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.

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. 

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.
 

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