Regulatory Affairs Specialist – Frestedt Incorporated – Minneapolis, MN
Frestedt Inc is growing and needs an experienced Regulatory Affairs specialist with experience in Clinical Research. Knowledge of Quality Systems and Biomedical engineering is an asset. The ideal candidate will have hands-on experience in medical devices, drugs or foods. Frestedt Inc is a small, agile work environment where good people work on good projects with good process. You’ll work with a strong internal team and an experienced management team who believes in doing excellent, detailed work. We are proud to deliver our products and services to our clients. We value each employee, we learn from our past experiences, we celebrate our successes and we have a little fun along the way.
To complete Clinical, Regulatory, Quality and Engineering (CRQE) projects for pre-and post-market products in compliance with regulations, quality standards, commitments and goals.
Essential Functions and Responsibilities:
Manage projects including planning, implementing, prioritizing, taking meeting minutes and entering/analyzing data to keep projects on time, high quality and within budget.
Complete project assignments (including, for example, clinical research studies/clinical evaluation reports, regulatory submissions, quality management systems, engineering reports).
Follow internal and external SOPs, Work Instructions and Forms/Templates to prepare robust, high quality deliverables and complete quality improvements.
Read, analyze and implement client projects across multiple industries and disciplines compliant with relevant regulations, standards and guidance documents (e.g. FDA, EU, cFDA, TGA).
Develop materials for on-line and in-person training (e.g. PowerPoint presentations).
Conduct literature searches and communicate scientific content in a clear, concise manner.
Other duties as assigned.
Master’s Degree or PhD (preferred)in a science-related field or equivalent work experience.
At least 3 years clinical, regulatory, quality and/or engineering work experience.
Advanced computer skills with Outlook, Word, Excel, PowerPoint and other software tools.
Able to productively interact with Frestedt Inc. staff and client companies including corporate executives, research sites and research subjects.
Must be focused, efficient, detail oriented and able to work independently.
Able to travel to client sites as needed (approximately 20% travel).
Demonstrated ability to manage and execute projects on time and on budget.
Must have excellent critical-thinking and problem-solving skills.
Able to coordinate and conduct training sessions and to secure required training documentation.
Able to reprioritize immediately as new projects arrive.
Passion for clinical research, regulatory, quality and engineering affairs activities for pharmaceutical, medical device and food industries.
This is not a remote work opportunity. Candidate must be local and able to work in our offices in St. Louis Park, MN. No relocation offered.
About Frestedt Incorporated
Frestedt Incorporated is an unparalleled consortium of over 70 knowledge experts working in an innovative, virtual setting to keep our service quality of the highest caliber and our costs as low as possible. The Frestedt Incorporated team works to solve problems with a forward thinking approach designed to provide all deliverables within tight timelines and budgets. We are a dynamic partner, focused on providing exactly the right solution to meet our client’s needs and we hold ourselves to the highest standards in everything we do. We provide support in running clinical trials and negotiating with regulatory authorities, and we build quality systems and training sessions designed to secure the release of our client’s products and claims to the market.
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