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
Job Summary
Entry-level position that gives the opportunity to gain hands-on learning experience about regulations within the medical device industry, assist members of the Regulatory Affairs team by providing organizational and informational support for global regulatory activities, and gain exposure to the development process associated with bringing a new product to market.
Essential Job Duties and Responsibilities
- Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics’ 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.
Qualifications
Training and Education
Bachelor’s degree or equivalent. May also be actively enrolled in a degree program. Science background is preferred.
Experience
No previous experience required.
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.
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).
