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Regulatory Affairs Associate

This job posting is no longer active.

Location: Salt Lake City, UT, United States
Position Type: Unfixed Term
Job Function: Regulatory Affairs

A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For almost 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 44 countries and serve 160 countries with the support of a large distribution network. This includes our SLC site, formerly known as BioFire Diagnostics.

Description

Essential Job Duties and Responsibilities:
  • Organize, update, and maintain regulatory documentation in accordance with company policy and procedures.
  • Assist in audit preparation when needed.
  • Support review and maintenance of product labeling.
  • Aid in the completion of the following tasks:
  • Assist with the preparation of regulatory submissions globally.
  • Initiation, collection, and coordination of information for regulatory documents for various purposes.
  • Coordination with global/local RA counterparts to obtain product approvals and renewals.
  • Conduct research about new regulations and guidance documents.
  • Develop and review corporate and department procedures.
  • Begin to be able to analyze and understand regulatory requirements and identify solutions; provide possible suggestions for implementation.
  • Ensures accurate population of databases for tracking global product registrations.
 
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.
 
Training and Education:
              Bachelor’s degree or equivalent.  Science background preferred.
 
Experience:
              1+ years in regulatory affairs or equivalent.  Medical device/IVD industry preferred.

Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMérieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bioMerieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers site https://careers.biomerieux.com/ or contact us at [email protected].

BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMérieux’s or its affiliates’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).

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