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Sr. Manager, RA Microbiology

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.

Position Summary:

This role manages a team people, which may be located in the US and/or France. In addition, the role will define, develop and implement regulatory strategies & policies for the successful and fast worldwide registration of IVDs belonging to the Microbiology Franchise.  The job responsibility includes, overseeing regulatory approvals for Europe (CE Marking), the US (FDA), and China (NMPA).

 

Lastly, the role will ensure that relevant corporate regulatory processes are established, continuously improved and followed.

 

Primary Duties:

  • Reports to Director of Regulatory Affairs,
  • Develop and implement regulatory operating guidelines/SOPs and common work practices/strategies within the team, supported by an efficient regulatory watch,
  • Oversee and ensure compliance with regulatory procedures and work practices,
  • Review, analyze and report on the effectiveness of the regulatory processes (definition of KPIs),
  • Provide expertise in translating regulatory requirements into practical, workable plans,
  • Ensure timely execution of regulatory submissions in line with company strategies,
  • Establish registration plans and review periodically with relevant contacts to ensure that resources are efficiently deployed,
  • Assist in drafting and validating answers to questions from regulatory authorities; monitor progress and escalate delays, problems as necessary,
  • Attract and develop the relevant profiles and competencies for an efficient RA organization and ensure human capital planning,
  • Maintain a positive team spirit and lead by ethical principles,
  • Establish, consolidate and monitor department budget.

 

Postion Requirements:

  • 6+ years of experience in the field of IVD's/MDs in an international environment
  • Bachelor's Degree in a scientific discipline required. Master's Degree preferred. 
  • Excellent knowledge and understanding of regulatory submissions with Health Authorities 
  • Exhibit leadership skills,
  • Experience managing and coaching staff (also remotely), at ease in an international environment,
  • Participation to local and/or international trade associations,
  • Good understanding of QMS requirements (design and change control processes), as well as of audits/inspections.
  • Ability to work in an international environment (which may include remote management of teams in France and/or the US),
  • Mentor and share experience,
  • Strategic and analytical thinker, problem solver, and planner with excellent organizational skills,
  • Capacity to influence, challenge and negotiate,
  • Clear communication to internal/external stakeholders.

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).

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