Clinical, Regulatory, Quality and Engineering (CRQE) Manager

Posting Date: 05/09/2019
Closing Date: 07/09/2019
Posting Level: Mid-Level

Talencio’s client, Frestedt Inc., is a full-service strategic partner providing targeted solutions in Clinical, Regulatory, Quality and Engineering Affairs within the Medical Device, Pharmaceutical, Biotech and Food Industries. Frestedt Inc. has a solid and growing client base and a strong reputation in the industry for delivering exceptional work. A familiar client response is, “Really like the depth of knowledge, organization and ability to understand clients’ projects.”

Frestedt Inc. is growing their team of “Good People Working on Good Projects using Good Processes”, and is hiring a hands-on leader reporting to the founder and CEO. The leader will manage technical projects and staff while providing leadership and assistance in achieving company goals and objectives. This is an excellent opportunity to work on a wide range of technologies and solutions.


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., ICH E6, GHTF/IMDRF, ISO 9001, ISO 14155, ISO 14971).
• Regulations (e.g., US 21CFR regulations for NDA/PMA, 505(b)(2)/510(k), EU MDR for
Design Dossiers, Technical Files, CE Marking, clinical safety reporting, etc.).
• Guidelines (e.g. US FDA guidelines, 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 clients and regulatory authorities and
publishing scientific works) to achieve client and company goals.
• Complete technical writing projects.
• Manage and support project activities and teams (e.g., plan, implement, execute and
prioritize projects to ensure meeting of deadlines and budget and delivering a high-quality
product and service).
• 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


Qualifications:


• At least 10 years experience in at least one of the following areas: clinical, regulatory,
quality and engineering.
• 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.
• Expert project manager including: 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 staff, executives, clients and research sites as well as
research subjects.


Requirements:


• Focused, efficient, detail oriented and able to work independently.
• Able to travel to client sites as needed (up to 20% travel).
• Excellent critical thinking and problem-solving skills.
• Able to coordinate training sessions and to secure the required training documentation.
• Able to effectively reprioritize activities.
• Passion for clinical research, regulatory, quality and engineering affairs.
• Committed to completing projects.


Qualified candidates, please submit resumes to swyatt@talencio.com


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