International Regulatory Affairs Specialist
This job posting is no longer active.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
What will be your activities at bioMrieux?
The Regulatory Affairs Market team is looking for a Regulatory Affairs Specialist to support Latin America & Canada region in a dynamic regulatory context.
The Regulatory Affairs Market team composed of 9 people is in daily contact with the local regulatory teams (subsidiaries and distributors) in order to guarantee the regulatory compliance of the products (reagents, instruments and software) for EME-AFRICA-ASPAC-LATAM region.
Reporting to the Regulatory Affairs Market Manager, your main responsibilities will be:
- Be the privileged point of contact point with subsidiaries and distributors. Lead regular follow-ups with the countries (progress of files, new regulations, etc.) and work closely with LATAM Regional RA and other Global functions.
- Responsible of Regulatory activities for a range of products :
- Contribute to the development of the regulatory strategy
- Coordinate and prepare the registration and renewal dossier within the defined deadlines in order to send it to the local regulatory contact.
- Ensure the traceability of these shipments in the regulatory database and ensure reporting.
- Follow-up of regulatory activities until approvals
- Responsible for the regulatory watch of a group of countries in order to identify any change having an impact on the product development and/ or leading to new regulatory activities
- Contribute to different working groups for transversal projects
Position Requirements:
-Bachelor's Degree in a scientific discipline
-Regulatory Affairs Specialist: 1+ years of professional experience in regulatory affairs, either in medical devices or in a "Region" position.
-The ability to speak and write in both Spanish and English is required.
You have high level of organization in your work, are detail oriented with good communication skills. You are also able to change easily your priorities and work on many subjects at the same time.
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).
