BSI Group

Microbiologist

US-GA-Atlanta
Category
Healthcare
Contract Type
Perm Full-Time
Salary
Competitive Salary

About the Role

Responsible for managing BSI activities in the assigned specialist technological area of sterilization and microbiology, ensuring the utilisation of appropriate technical expertise for reviewing medical devices technical documentation and quality systems and attending assessments as technical expert or providing expert briefing. The individual is also responsible for planning, reporting and performing of audits of clients’ management systems ensuring compliance with regulatory and voluntary requirements. This is a homebased role with up to 50% travel.

 

Essential Responsibilities:

  • Manage between 50 and 100 (depending on complexity and risks) allocated clients, with responsibility to deliver an agreed revenue. The job holder is expected to maintain a position of leadership in the assigned industry sector, recognised and acknowledged by external agencies (Medicines and Healthcare Regulatory Agency, Food and Drug Administration, USA, Trade Associations) as an expert.
  • Responsible for planning, reporting and performing of audits of clients’ management systems ensuring compliance with regulatory and voluntary requirements. This aspect of the job involves significant travel and time away from home.
  • Conduct comprehensive in-depth medical device reviews (including sterilization validation). These reviews will often be of devices that represent the cutting edge of knowledge and practised technology where no product standards or device experience exists, in these cases the job holder will draw on significant knowledge and experience to make a reasoned judgement on product safety. When working in this area it is essential that the job holder is competent to identify when additional specialist expertise is required and is capable to review such work.
  • Must be competent to analyse risks against benefits, in an environment where a favourable decision from the notified body will potentially lead to very large commercial benefits for the device manufacturer. Must also be capable and competent to make recommendation to withdraw a certificate and deny a device market access.
  • Determines when to make a recommendation to issue a certificate, based on objective evidence that the device is safe and effective.
  • Manage major clients to ensure medical devices group maintains customer satisfaction and profitability. Client management will include major client management of global device manufacturers with thousands of individual of devices. Develop proposals and plans for major client management, and project plan the launch of new devices through the regulatory process. Also responsible for negotiating effective utilisation of resources to protect the integrity and accreditation of the approval process and deliver cost benefits to BSI and client.
  • Responsible for financial and regulatory performance of all managed activities to include confidentiality, impartiality and conflict of interest requirements.
  • Design Dossier Reviews — Initial reviews completed within 5 working days, full review completed within 30 working days.
  • Certificate Recommendations — Ensure that no unsafe certificates are issued.
  • Briefing notes—Provide adequate technical briefing notes, where required, for technical visits.
  • Profitability— Maintain control over costs of all visits and reviews to achieve satisfactory profits.
  • Regulatory Compliance— Ensure all activities exceed the regulatory and accreditation requirements expected of the group.
  • Major Account Management— Manage a portfolio clients including major accounts.

About You

Education/Qualifications: 

  • Bachelor degree required or equivalent level in Microbiology with a minimum of 3 years in-depth experience in working as a microbiologist in the manufacture of sterile products (medical devices or pharmaceuticals).
  • Customer and Personal Service — Knowledge of principles and processes for providing customer and personal services. This includes customer needs assessment, meeting quality standards for services, and evaluation of customer satisfaction.
  • Administration and Management — Knowledge of business and management principles involved in strategic planning, resource allocation, human resources modelling, leadership technique, production methods, and coordination of people and resources.

About BSI

Our ambition is to be recognized and valued globally as a best-in-class company; a client-driven, efficiently-run, growing business.  BSI has come a long way since being founded in 1901. Today, we're a global business services organization, respected world over for the development of standards; assessment of management systems; testing and certification of products and services; providing software solutions; and the delivery of training courses. We offer diverse career paths from auditing to sales, product development to finance, and from IT to marketing.

 

With around 4,000 employees working with over 80,000 clients in 172 countries it means that career opportunities are vast. BSI challenges mediocrity and complacency to help embed excellence into the way people and products work. That means showing businesses how to improve performance, reduce risk and achieve sustainable growth.

 

Our Vision: "To be the global business improvement partner of choice.”

Our Mission: "To help organizations embed excellence", and states our shared purpose.

Our Values: "Integrity - Continual improvement - Inclusivity", guide us in the way we work and help us deliver our Vision and Mission.

 

What we offer:

 

BSI offers a competitive salary, group-sponsored health and dental, short-term and long-term disability, a company-matched 401k plan, company paid life insurance, 11 paid holidays and 4 weeks paid time off.

 

BSI is an Equal Opportunity Employer and we are committed to diversity.

 

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