- load_list_page(event)"> Job listing - Job details Job Information - Date Opened 01/09/2025 - Job Type Full time - Work Experience 1-3 years - Industry Manufacturing - City Pardi - State/Province Gujarat - Country India - Zip/Postal Code 396191 About Us MERIL DELIVERING WORLD-CLASS HEALTHCARE SOLUTIONS Founded in 2006, Meril is an India-based, global medical device company that is dedicated to the innovation, design and development of novel, clinically relevant and state-of-the-art devices. Our fundamental aim is to champion the alleviation of human suffering and improve quality of life. To enable this, we are committed to R&D, innovation in manufacturing medical technology, scientific communication, and contemporary distribution avenues. Meril was born with the aim of improving the quality of human life through innovative and advanced healthcare solutions. As a medical device manufacturer, we exist to improve the inventiveness in healthcare so that people’s lives are enriched. We continually seek excellence in providing answers to some of medicine’s toughest questions. Meril manufactures medical solutions in the form of vascular intervention devices, orthopaedic supplements, in-vitro diagnostics, endo-surgery and ENT products. It is our core commitment to ensure the delivery of advance healthcare solutions. Our inclination towards research and development is reflected in our diverse offerings. We ensure that we adhere to the best quality of standards in manufacturing, scientific communication and distribution to deliver path-breaking healthcare products to the world. We collaborate with physicians and global innovators to identify unmet clinical needs and develop revolutionary therapies. We encourage research and academic collaborations and remain available to interact on exciting opportunities. Headquartered in India with a manpower of more than 4000, Meril currently conducts business in more than 100 countries. We have 100% subsidiaries in India, USA, Germany, Brazil, Russia, South Africa, Bangladesh and Turkey. We have set up operations in China and Japan too. Job Description - To develop and write clinical evaluation reports (CER) for pre- and post-market devices, while ensuring consistency with regulations, quality standards, commitments and goals. - Writing coherent, convincing CERs by organizing and evaluating large amounts of scientific/clinical/medical data. - Managing CER writing by planning, identifying, appraising and analyzing clinical data then writing the CER including conclusions based on expert knowledge. - Ensuring quality by following internal and external SOPs, Work Instructions and Forms/Templates for successful preparation of robust CERs and other documents - Assisting with other clinical, regulatory, quality and engineering projects as assigned - Responsible to acquire, interpret, analyze and draw conclusions from clinical data from clinical trials, literature and experiences for a wide variety of medical devices - Responsible to communicate scientific content in a clear, concise manner - Other duties as assigned Requirements - Must be focused, efficient, detail oriented and able to work independently. - Able to read, analyze and implement regulations, standards and guidance. - Demonstrated ability to manage projects (take minutes, multi-task, prioritize and ensure reliability and quality while executing projects on time and on budget). - Strong written and oral communication skills. - Bachelor's or Master’s Degree or PhD (preferred) in a scientific discipline. - At least 1-3 years CER writing experience with solid knowledge of Med Dev 2.7/1, rev 4. - At least 1-3 years clinical, regulatory, quality and/or engineering work experience. - Able to productively interact with teams including corporate executives, research sites and research subjects. - Advanced computer skills with Word, Excel, PowerPoint, etc. Benefits - Fresh Perspectives - Enhanced Skills and Expertise - Increased Productivity - Improved Morale - Broadened Network - Diversity and Inclusion - Knowledge Transfer check(event) ; career-website-detail-template-2 => apply(record.id,meta)" mousedown="lyte-button => check(event)" final-style="background-color:#749DDB;border-color:#749DDB;color:white;" final-class="lyte-button lyteBackgroundColorBtn lyteSuccess" lyte-rendered="">