Regulatory Affairs Specialist
Location: Saint Louis, 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.
Main Accountabilities:
- Conduct research on regulatory changes and developments and on application requirements and process,
- Assist in the development and review of procedures,
- Advise responsible personnel on regulatory requirements and develop options with recommendations; develop product regulatory strategy; assess continuously project output and impact on regulatory strategy and launch date,
- Validate product labels, instructions for use, advertising and promotional materials,
- Compile and organize content of regulatory applications and files; assess acceptability and completeness of documents; identify unmet needs and provide feedback; ensure filing and timely retrieval,
- Interact with regulatory authorities and execute regulatory processes; provide feedback on application review progress and questions; coordinate and review answers to questions; report on issues.
Studies and Experience:
- Bachelor's Degree required
- Knowledge of regulatory requirements, guidance documents and processes (local/regional) with more than 5 years of practice in the field of IVD/MD in an international environment,
- Basic knowledge of QMS requirements (QSR and ISO 13485 and/or local GMP if appropriate) with developed knowledge of design and change controls,
- Familiar with product profiles and technology, with company organization and processes,
- Familiar with regulatory agency organization (e.g. US FDA, EU Notified Bodies, and China NMPA),
- Participation in local professional, trade organizations
Skills and Qualifications:
- Analyze, understand regulatory requirements and identify solutions; provide directions for proper implementation,
- Routine problem solving,
- Develop regulatory rationales and justify the reasoning,
- Communicate to internal stakeholders and regulatory agencies or their representatives.
- Ability to work in an international environment.
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).
