Regulatory Affairs Assistant
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
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.
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).
