NGK Spark Plugs

Job Locations US-CA-Santa Clara
Job Title
VL - Senior Regulatory Affairs Specialist
Job ID
2022-2252
Category
Innovation
Department
Innovation
Type
Regular Full-Time

Overview

About Global Smart Health

The Global Smart Health group is focused on new business creation in digital health in Japan, Europe and Silicon Valley, working together with the NGK Venture Labs to expand our portfolio with M&A, strategic investments and partnerships globally.  We are on a mission to develop innovative business solutions that tackle tomorrow’s challenges. Our team actively seeks opportunities to work with the brightest entrepreneurs and industry leaders to launch new businesses in the areas of smart health and is a diverse group of individuals that all share passion, drive, and an open mind towards improving the world and building a better future for all.  

 

The Ideal Candidate: 

Are you a passionate individual with extensive regulatory experience in medical devices who wants to transform the future and develop innovative ideas into tangible healthcare solutions? Then you are the person we are looking for to join the Global Smart Health team! 

 

The Role: 

Function as a Regulatory Affairs subject matter expert on new product introduction, clinical, manager and engineering design control teams. This includes conducting reviews and providing expert regulatory feedback for specifications, device testing, risk management, and other relevant documentation in accordance with regulatory requirements and with positioning for regulatory submission. Manage, prepare, and support regulatory submissions required for device approvals and registrations in the US and globally. Collaborate with global teams and portfolio companies on international approval efforts.

 

You will own all of the functional aspects of regulatory affairs including project management, documentation of requirements and timeline, resolution of open issues, communication of status and more. You will build the foundations of the process that will help scale and establish working relationships with B2B customers to for feedback and trends to help us drive continuous improvements and offerings.

Responsibilities

  • Develops strategies to ensure the company’s production activities comply with government regulations
  • Serves as a liaison between regulatory bodies and operating divisions of the company
  • Prepares and submits applications and reports to applicable regulatory agencies
  • Responds to requests for information from regulatory bodies
  • Coordinates with operations departments regarding production design and development to ensure compliance with regulations
  • Assists with the development of standards for the company’s operating and production procedures
  • Maintains current knowledge of regulations applicable to the company
  • Monitors regulatory affairs and the effect changes will have on company operations
  • Develops and maintains professional relationships in federal, state, and local regulatory agencies
  • Work closely with internal and external teams to ensure accurate implementation, compliance of designs
  • Perform job related travel
  • Adhere to all company policies and procedures and, if applicable, all company policies relating to IATF16949 and ISO14000

Pay Scale:

  • In the spirit of pay transparency, we are excited to share the base salary for the position is $78,500-$94,000, exclusive of fringe benefits or potential bonuses.

Qualifications

Bachelors/Master’s Degree in Life Sciences or related field

5+ years relevant experience in medical devices, preferable premarket devices

Experience in large company and start-up environment.

Extensive knowledge of applicable government regulations.

Ability to inform and educate managers and department heads on regulations and policies that require compliance.

Demonstrated verbal, written and interpersonal communication skills, including the ability to conduct verbal presentations.

Demonstrated success working in a team environment.

Demonstrated in-depth knowledge of ISO standards and systems.

Demonstrated experience in implementation of Quality systems: US FDA 21CFR 820 QSR, IVDR, European MDR/MDD.

Ideal Candidate will also have experience with Japanese PDMA.

Demonstrated experience with internal and external audit processes.

Proficiency with Microsoft Office applications (Word, Excel, PowerPoint)

Medical Writing experience is preferred

Time management skills and ability to multi-task with individual initiative (self-starter) 

Possess a valid driver’s license and an acceptable driving record

Possess mental faculties consistent with performing at least the minimum essential functions of the job

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