To manage and complete technical projects and staff while providing leadership and assistance in achieving company goals and objectives.
Essential Functions and Responsibilities
- Perform essential operational management functions and contribute to each work product or service as needed to meet company goals and objectives.
- Ensure technical operations meet corporate goals and staff are fully engaged.
- Oversee and contribute to projects to ensure each project also meets:
- Quality Management System requirements (e.g., Quality Manual, SOPs, Work Instructions and Templates)
- Standards (e.g., ISO 9001, ISO 14155, ISO 14971)
- Regulations (e.g., EU MDR for Design Dossiers, Technical Files, CE Marking; US 21CFR regulations for NDA/PMA, 505(b)(2)/510(k), clinical reports)
- Guidelines (e.g. Med Dev 2.7/1 for Clinical Evaluation Reports, etc.)
- All project specifications
- Clearly communicate and lead/mentor/guide team members with full engagement (e.g., from completing tasks like logging in documents, searching for relevant information and evaluating project quality to negotiating with regulatory authorities and publishing scientific works) to meet company goals.
- Complete technical writing projects.
- Manage and support project activities and teams (e.g., planning, implementing, executing and prioritizing work to keep projects on time, high quality and within budget).
- Review projects to ensure quality improvements are ongoing and effective.
- Report activities to CEO and work to optimize all CRQE activities to meet client needs and company objectives.
- Provide training and engagement services for clients, as directed.
- Advocate for the business, promote Frestedt Inc. services, network and be a positive contributor to the larger community to drive business expansion.
- Other duties as assigned
- At least 10 years clinical, regulatory, quality and/or engineering work experience with documented ability to multi-task, prioritize and ensure reliability.
- At least 4 years management experience.
- Advanced degree (MD, PhD, MBA, MS) in a medical or science-related field preferred.
- At least 5 years exposure to FDA, EU regulations and processes with the ability to read, analyze and implement regulations, standards and guidance documents across multiple industries and disciplines.
- Expert qualification with documented project management experience showing organizational, time-management, written and oral communication and people management skills.
- Advanced/expert experience using Outlook, Word, Excel, PowerPoint, and other software tools.
- Extensive and documented experience with technical writing.
- Ability to productively interact with Frestedt Inc. staff, corporate executives, client companies and research sites as well as research subjects.
- Must be focused, efficient, detail oriented and able to work independently.
- Able to travel to client sites as needed (approximately 20% travel).
- Must have excellent critical thinking and problem-solving skills.
- Able to coordinate training sessions and to secure the required training documentation.
- Able to reprioritize immediately as new projects arrive.
- Must have passion for clinical research, regulatory, quality and engineering affairs activities for pharmaceutical, medical device and food industries
- Must have a commitment to completing projects
Interested applicants can send their resume and cover letter to firstname.lastname@example.org with the CRQE Manager in the subject line.