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Regulatory Affairs Specialist

2 months ago

Raleigh, United States Randstad Life Sciences US Full time

A global medical device company continuously innovated with new products and technologies that revolutionize treatments for doctors and their patients.

The Regulatory Affairs Specialist will assist or lead a variety of regulatory tasks in support of global regulatory strategy, regulatory assessment for modified product, regulatory filing for new/modified product, regulatory operation and processes, post-market surveillance. This role requires strong organization, written and oral communication skills, and must be able to perform tasks with accuracy and a high attention to detail.

In this role, you will...

  • Perform regulatory assessments for product changes including regulatory reportability decisions
  • Work with cross functional team and international regulatory colleagues to develop and implement global regulatory strategy to support business global expansions
  • Support regulatory filing like a 510(k) or Pre-submission or a new/amended Health Canada License application for a Class II new product and may include renewal of Licenses
  • Support international regulatory filing
  • Assist in streamlining or updating regulatory processes
  • Assist in regulatory intelligence activities
  • Assist in post-market surveillance activities, such as complaint handling and vigilance reporting
  • Assist in regulatory involved QMS activities, such as CAPA, Non-Conformance
  • Perform other related assignments as required

In this role, you'll need ...

  • Bachelor's degree in Science, Engineering, Regulatory, a medical field, or an equivalent educational background with a focus on technical writing, scientific methodologies, and problem-solving.
  • Must be available to work with a hybrid schedule (3 days in office, 2 days remote) in office:
  • 1-2 years experience in medical device industry. Experience of medical device, SaMD development, or regulatory affairs is preferred
  • Knowledge of US regulation in medical device is required
  • In-depth knowledge and skills with computer applications and business tools such as e-mail, MS Word, Excel, PowerPoint
  • Motivated and quick to learn new concepts and understand technical writing and medical device regulations
  • Proficient written and oral communication skills
  • Organized and detail-oriented
  • Ability to manage work effectively in a remote capacity in a fast-paced, dynamic but often ambiguous workplace