Clinical Research Associate

5 days ago

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RQM+

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RQM+ is a global MedTech service provider that accelerates compliance and market success for medical device and in vitro diagnostics (IVD) companies. Offering comprehensive services throughout the product lifecycle, RQM+ specializes in regulatory and quality consulting, lab services, clinical trials, and reimbursement strategies. With a team of seasoned consultants, many of whom are former FDA and EU regulators, the company provides unmatched expertise in handling complex regulatory environments. Jordi Labs, a subsidiary, enhances the service offering with advanced materials science and chemical characterization capabilities. RQM+ utilizes innovative platforms like Fern. ai to streamline regulatory documentation and expedite market entry for life-saving medical technologies.

Regulatory for Medical Device • Quality Systems for Medical Device • Design Assurance for Medical Device • Product Quality for Medical Device • Post-Market Surveillance for Medical Device

501 - 1000 employees

⚕️ Healthcare Insurance

🧬 Biotechnology

🤖 Artificial Intelligence

📋 Description

• RQM+ is the leading MedTech solutions partner, accelerating the product lifecycle from innovation to patient impact. • Applies end-to-end expertise to propel products from concept through market entry and ongoing post-market support. • Delivers unmatched regulatory and quality expertise, comprehensive clinical trial design and execution, and impactful reimbursement strategies. • Collaborates closely with manufacturers across device types and therapeutic areas to deliver life-changing technologies to patients. • Participates in preparation and execution of pre-market to post-market clinical trials.

🎯 Requirements

• Bachelor's Degree in scientific discipline or health care preferred. • Requires at least 2 years of on-site monitoring experience. • 2-3 years in-house or remote monitoring experience • Equivalent combination of education, training and experience considered • In-depth knowledge of, and skill in applying, applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. MedTech regulations and active experience preferred. • Strong therapeutic and protocol knowledge as provided in company training. • Computer skills including proficiency in the use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and mobile technology required. • Written and verbal communication skills including command of English language. • Organizational and pragmatic problem-solving skills • Effective time and financial management skills • Ability to establish and maintain effective working relationships with coworkers, managers, sponsor staff and sites. • Ability to travel up to 50%

🏖️ Benefits

• Industry leading compensation package • Focus on work life balance • Ongoing learning and development