Language English |
RegionGlobal | APAC

Emerge Global Reach

Asia

pin China English
|
Chinese
pin India English
pin Indonesia English
|
Indonesian
pin Japan English
|
Japanese
Russia English
|
Russian
pin Singapore English
|
Chinese S

Europe

pin Czech Republic English
|
Czech
France English
|
French
Germany English
|
German
pin United Kingdom English

The Americas

Canada English
|
French
Latin America English
|
Spanish
pin United States English

Australia

JOBS

Are you looking for the opportunity to make an impact?

Country

Industry

location

Job Description:

The Senior Regulatory Affairs Specialist is an incredible opportunity to join a fast-growing global medical device company.

This position is responsible for urgent regulatory affairs projects, and requires strong technical knowledge and ability to work with the engineering team. This position is located in the Western suburbs.

Responsibilities

  • Ensure compliance and approve reports.
  • Lead regulatory affairs projects.
  • Prepare submissions to regulatory agencies.
  • Collaborate across all departments and with all levels within the organization.
  • Develop plans for complicated projects
  • Stay updated on on future regulatory trends.
  • Review all marketing material and product labeling to ensure compliance. Qualifications:
  • Must have at least 4 years of experience working with the FDA and international regulatory.
  • Bachelor’s degree. MBA preferred.
  • Knowledge and of international regulations, as well as US Class II and III devices