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Quality Systems and Regulatory Affairs Specialist Pipeline

Medtronic


Location:
Seoul
Date:
24-12-2020
2020-12-242021-01-29
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Job Details

Quality Systems and Regulatory Affairs Specialist Pipeline

Location:

Seoul, Seoul, Korea

Requisition #:

20000M9G

Post Date:

Dec 18, 2020


**CAREERS THAT CHANGE LIVES**


At Medtronic, we value what makes you unique. Be part of a company that thinks differently to solve problems, make progress and deliver meaningful innovations.


**SEEKING EXPRESSIONS OF INTEREST FOR QUALITY SYSTEMS AND REGULATORY AFFAIRS SPECIALIST ROLES IN KOREA.**


**_Disclaimer: This posting is intended to pipeline talent for existing and potential future needs. Please note there will be a delay in the review of applications received over the Christmas New Year period as we break for the holiday season. We appreciate your patience and will be in touch as soon as possible after this time._**


You will have the opportunity to be part of our market leading technology across a broad range of products in medical devices as Quality Assurance Specialist or Regulatory Affairs Specialist. Working within a high performing collaborative team, you will be able to achieve your career aspiration while positively impacting patient lives!


**Come for a job, stay for a career!**


**A DAY IN THE LIFE**


**QUALITY SYSTEMS SPECIALIST:**


+ Typically, an individual contributor role and will be reporting to the Quality Systems Manager and will be based in our Glass Tower, Seoul Office. This is a unique opportunity to join the Quality Systems Team to ensure the quality programs, systems, processes and procedures that ensure compliance with policies. You will be an experienced Quality Systems Specialist, having had at least 2 years relevant experience within medical devices/ Pharma. It is a wonderful opportunity over time, to take your monitoring career towards your career growth in medical technology and device research.


**Key Responsibilities:**


+ Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that

+ ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.

+ Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.

+ Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.

+ Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.

+ Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.

+ Co-ordinates legal requests in support of government investigations or litigations.

+ Ensures the quality assurance programs and policies are maintained and modified regularly.

+ Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of companys mission globally.


**REGULATORY AFFAIRS SPECIALIST:**


+ Typically, an individual contributor role and will be reporting to the Senior Regulatory Affairs Manager and based in our Glass Tower, Seoul Office. This is a unique opportunity to join the Regulatory Affairs Team to ensure the appropriate licensing, marketing and legal compliance of a range of our medical devices in order to control their safety and efficacy.


**Key Responsibilities:**


+ Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.

+ Leads or compiles all materials required in submissions, license renewal and annual registrations.

+ Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.

+ Monitors and improves tracking / control systems.

+ Keeps abreast of regulatory procedures and changes.

+ May direct interaction with regulatory agencies on defined matters.

+ Recommends strategies for earliest possible approvals of clinical trials applications.


**Must Have: Minimum Qualifications**


**QUALITY SYSTEMS SPECIALIST:**


+ Bachelors Degree Required in Medical/ biological science/ nursing or equivalent field

+ Prior experience in a Quality Specialist role is essential, with 2 to 3 years of relevant experience

+ Excellent stakeholder relationship management

+ Outstanding communication and interpersonal skills

+ Strong ability to work well within a team and autonomously

+ Achievement oriented and ability to drive results with the highest quality standards

+ Computer skills (excellent knowledge of MS Office products).

+ High attention to detail and accuracy

+ Good prioritization and organizational skills.

+ Excellent problem-solving skills

+ Bi-lingual proficiency in English and Korean language


**REGULATORY AFFAIRS SPECIALIST:**


+ Bachelors Degree Required in medical/biological science/nursing or equivalent field

+ Prior experience in a Regulatory Affairs role is essential, with 2 to 3 years of relevant experience

+ Excellent stakeholder relationship management

+ Outstanding communication and interpersonal skills

+ Strong ability to work well within a team and autonomously

+ Achievement oriented and ability to drive results with the highest quality standards

+ Computer skills (excellent knowledge of MS Office products)

+ High attention to detail and accuracy

+ Good prioritization and organizational skills

+ Excellent problem-solving skills

+ Bi-lingual proficiency in English and Korean language


**ABOUT MEDTRONIC**


Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.


We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Lets work together to address universal healthcare needs and improve patients lives. Help us shape the future.
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.
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