As a key member of our team, we are seeking an experienced Medical Writer to join our ranks. The successful candidate will be responsible for preparing Clinical Evaluation Reports (CERs) and Post-market Surveillance Plan literature reviews. The ideal candidate will have a strong background in medical writing, clinical affairs, regulatory affairs, or product engineering in the medical device industry. A minimum of a Bachelor's degree in health, life sciences, engineering or a similar discipline is required. Experience with statistical methods, data analysis, and interpretation is highly valued. Key responsibilities include: - Preparing CERs and PSPs for regulatory submissions - Conducting systematic literature searches of peer-reviewed publications - Summarizing data and drafting risk versus benefit analyses - Collaborating with cross-functional teams to ensure accurate and compliant reports To excel in this role, you will need excellent written and verbal communication skills, as well as the ability to work independently and as part of a team. You will also be expected to maintain high standards of quality and attention to detail. Benefits of working with us include: - A dynamic and supportive team environment - Opportunities for professional growth and development - Competitive compensation and benefits package - Flexible work arrangements to suit your needs We are committed to fostering a culture of diversity, equity, and inclusion. If you share our values and are passionate about delivering exceptional results, please apply today! Requirements - Bachelor's degree in health, life sciences, engineering or a similar discipline - Minimum 2-5 years of experience in medical writing, clinical affairs, regulatory affairs, or product engineering - Proficient in English - written and spoken B2 - Excellent written and verbal communications skills - Demonstrated technical and medical writing competence Preferred Qualifications - MD, MS and PhD preferred - Experience with statistical methods, data analysis, and interpretation - Authorship of scientific publications in peer review journals For more information, please contact us at [insert contact information]. We look forward to hearing from you!