Rqteam

USA

Posted on: 20 March 2024

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Study Director

RQM+ is the leading MedTech service provider with the world’s largest global team of regulatory and quality experts. Building upon 40 years of regulatory expertise, we also provide comprehensive clinical trial, lab and reimbursement services – reducing risk and supporting market access throughout the entire product lifecycle for medical devices, digital therapeutics and diagnostics. With more former FDA, Medicines and Healthcare Products Regulatory Agency (MHRA) and notified body regulators than any other firm, the RQM+ team has deep expertise in all clinical specialties. RQM+ currently works for 19 of the top 20 medical device manufacturers and seven of the top 10 IVD companies.

The Study Director is responsible for organizing and leading projects for investigative and regulatory clients. The position includes fielding customer inquiries for regulatory testing services in conjunction with the project manager to ensure customer satisfaction. It is the responsibility of the study director to lead a team of chemists in the implementation of regulatory protocols to obtain accurate results.

Responsibilities:

Responsible for organizing and Leading Lab Services Regulatory and Investigative Programs.

Overall responsibility for the conduct of the study, as well as for the interpretation, analysis, documentation, and reporting of results

Point of contact for client & the link between RQM+ Lab Services and the client

Manages and communicates project timelines and budgets.

Performs functions in accordance with GLPs and other applicable regulations.

Consults with Sponsor, project manager and others during protocol development to optimize protocol design to appropriately address study objectives.

Responds to inquiries from clients and other relevant parties regarding scientific aspects of studies. Actively participates in client discussions regarding studies.

Monitors, tracks, and communicates study milestones throughout departments.

Ensures that all experimental data, including observations of unanticipated responses of the test system, are accurately recorded, and verified.

Ensures that unforeseen circumstances that may affect the quality and integrity of the study are noted when they occur, and that corrective action is taken and documented.

Manages and mentors a team of chemists in terms of lab responsibilities, analytical strategies, industry regulations and Jordi Labs' philosophies and culture

Requirements:

Master of Science or PhD in Chemistry or equivalent education/experience

Must be GLP/GMP Trained .

Excellent project management skills

Ability to multi-task

Excellent communication and negotiation skills

Critical thinking skills to navigate challenges, solve problems and drive compliance.

Working understanding of laboratory requirements, GxP guidelines, ISO guidelines, USP requirements and FDA and notified body guidance’s.

Excellent Business Acumen - Ensuring project decisions align with organizational goals.

Understanding of regulatory requirements and their application to each program.

Being an industry leader in Medtech is just the beginning for RQM+. We consider our employees our biggest asset and we invest heavily in ongoing learning and development. Providing a rewarding place to work is rooted deep in our core values. From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ has a unique offering for regulatory and quality professionals. At RQM+, you are not just another employee, you are a member of RQM+ family. Make your impact today!

We invite you to apply if you have an interest in learning more about our organization and beginning your journey with us.