Description

BioMerieux is looking for a Regulatory Affairs Assistant to join our growing team. The RA assistant will learn about regulations within the medical device industry and assist members of the Regulatory Affairs team by providing organizational and informational support for global regulatory activities.

Principal Job Duties and Responsibilities

• 
  Perform all work in compliance with company policy and within the guidelines of bioMerieux’s Quality System.
• Aid more senior regulatory specialists with the following tasks:
  • Initiation, collection, and coordination of information of regulatory documents for various purposes.
  • Preparation and maintenance of product technical files for CE marking.
  • Organization and preparation of documents for international submissions.
  • Coordination with international counterparts to obtain product approvals and renewals.
  • Conduct research about new regulations and guidance documents.
  • Assessment of product change impacts (device/labeling) for US and international markets.
  • Development and review of corporate and department procedures.
  • Adverse event reporting and field actions.
• Organize, update, and maintain regulatory documentation in accordance with department and company procedures.

Training or Education

• Bachelor’s degree or equivalent. May also be actively enrolled in a degree program. Science background is preferred.

Knowledge, Skills, and Abilities

• Ability to work effectively with multiple disciplines and personalities.
• Self-starter starter, with the ability to work and learn independently.
• Demonstrate initiative and can work both independently and collaboratively in a team structure.
• Strong attention to quality/detail.
• Strong interpersonal and communication skills (written and verbal).
• Ability to handle multiple tasks and priorities.
• Proficient with computer and standard software programs (Microsoft Office, Adobe Pro).
• Excellent organizational, time management, and administrative skills.