Role Overview
We are seeking a Regulatory/CER Writer for one of our valued clients on a permanent basis. This is a remote, full-time opportunity for an experienced professional skilled in regulatory writing and clinical evaluation reporting. The role focuses on producing high-quality regulatory documents and Clinical Evaluation Reports (CERs) in compliance with industry standards and guidelines.
Key Responsibilities
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Develop Clinical Evaluation Reports (CERs) and other regulatory documents
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Conduct literature reviews and analyze clinical data
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Write, edit, and proofread technical documents with accuracy and clarity
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Collaborate with cross-functional teams to gather and verify information
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Ensure compliance with current regulatory guidelines and standards
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Contribute to the development of regulatory strategies
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Stay updated on evolving industry requirements
Qualifications
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Experience in Regulatory Writing and CER Writing
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Strong skills in conducting literature reviews and interpreting clinical data
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Proficiency in technical writing and editing
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Solid understanding of regulatory guidelines and compliance standards
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Excellent communication skills and ability to work with cross-functional teams
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Detail-oriented with strong analytical and organizational abilities
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Ability to work independently and meet deadlines
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Bachelor’s degree in Life Sciences, Pharmacy, Medicine, or a related field
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Previous experience in the medical device industry is required
About MDJ Partnered Solutions
MDJ Partnered Solutions is a trusted recruitment partner dedicated to connecting the life sciences industry with top talent globally. We specialize in permanent and contract roles across pharmaceuticals, biotechnology, and medical device manufacturing.
Our collaborative, relationship-driven approach ensures long-term success for both clients and candidates. Leveraging a global network of specialized professionals in areas such as regulatory affairs, clinical, quality, and R&D, we provide tailored support to help organizations secure the right talent while guiding professionals in their career development.