- Admin – Health and Medical Services
- Admin – Publications and Editing
Regulatory and Quality Solutions LLC (R&Q) is the industry leader in providing regulatory and quality solutions to medical device companies. From strategy to tactical implementation, R&Q partners with clients by providing business balanced solutions and hands-on support that enhance the commercialization and post market processes for medical devices. Balancing the art and science of the regulatory and quality landscape has been the hallmark of R&Q’s mission and cemented it’s essence of the “and means more.”
We are seeking medical writers to support the development and creation of Clinical, Scientific, and Regulatory documents in accordance with procedures, European Medical Device Regulation, and US FDA requirements. This includes, conducting literature reviews, assisting and writing Clinical Evaluation Reports, analysis of product complaints and trends, collecting and analysing feedback from various sources to support the CER.
- Preparing, writing, editing, and reviewing regulatory (e.g. Clinical Evaluation Reports (CERs), clinical data reports or summaries) documents.
- Performing literature reviews for specific medical devices.
- Strong medical and technical writing skills
- Knowledge and understanding of proposed and current global regulations and guidance and the ability to relay the impact of such regulations and guidance internally and with our clients.
- Ensures documents are produced in accordance with procedures, internal and external guidelines (e.g. MEDDEV 2.7.1 Rev. 4)
- Knowledge of clinical research and regulatory requirements
- Preferred 2+ years of experience within the medical device industry and knowledge of clinical evaluation report regulatory requirements, evidence generation, and CER document creation
- PhD post doc candidates encourage to apply
- Or 3 – 5 year’s industry experience in medical writing in the healthcare industry or academia or in a related area such as quality, regulatory, clinical research, or product support.
- Experience with FDA and international regulations, requirements and guidance associated with clinical regulatory document preparations, submissions and reporting preferred.
Being an industry leader in client support is just the beginning for R&Q. Providing a rewarding place to work is rooted deep in the core values of R&Q. From an industry leading compensation package to a deeply engrained focus on work life balance, R&Q applies the “and means more” approach to employment. At R&Q, you are not just another employee, you are a member of the R&Q family. Make your impact today!
We are interested in every qualified candidate who is eligible to work in the United States. However, we are not able to sponsor visas.
Regulatory and Quality Solutions LLC