Regulatory Affairs Specialist I
This job posting is no longer active.
Location: Salt Lake City, UT, United States
Position Type: Unfixed Term
Job Function: Regulatory Affairs
A world leader in the field of in vitro diagnostics for more than 60 years, bioMérieux provides diagnostic solutions which determine the source of disease and contamination to improve patient health and ensure consumer safety.
In North America we have more than 6,200 team members across 11 sites or subsidiaries, including Salt Lake City-based BioFire Diagnostics and one subsidiary in Montreal, Canada.
Come and join a family-owned global company with a long-term vision, and a human-centered culture.
Description
Regulatory Affairs position within lifecycle management (LCM). Dependent on the level, responsibilities include contributing to or leading impact assessments and notification plans for product lifecycle changes, assessing applicable health authority regulations, assessing regulatory risks for products (for changes), and capturing and communicating global regulatory requirements for lifecycle management. This role may also help prepare submission files and communicate with Health Authorities to ensure global approval for product lifecycle changes. They may also perform and/or assist with medical device reporting or field actions. This position may require support from senior Regulatory Affairs members and/or managers.
- Organize, update, and maintain regulatory documentation in accordance with company policy and procedures.
- Perform and/or assist in the completion of the following tasks:
- Preparation of regulatory submissions and change impact assessments for changes in products on the market (US, EU, Global)
- Assessment of product impact analysis for regulatory assessment (all on market products).
- Collaboration with SME’s to provide feedback and/or create supporting documentation to provide to local regulatory bodies to support change submissions.
- Initiation, collection, and coordination of information of 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.
- Development and review of corporate and department procedures.
- Lifecycle documentation updates (IFU, technical documents) to support annual updates.
- Assist or participate in audits when needed.
- Support the review of labeling.
- Support or lead in understanding regulatory requirements and identify solutions; provide possible suggestions for implementation.
- Ensures accurate population of databases for tracking global product registrations.
- Ensures global contact lists and change notification tracking lists are maintained and kept up to date as changes are made.
- Lead and/or coordinate meetings and guide discussions regarding regulatory topics.
Qualifications:
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).
