Job Description

Tata Elxsi is known for its ability to create consumer delight, build loyalty, and drive revenue growth in the field of MedTech ER&D. From wearables for the health-savvies to critical medical devices and drugs that save thousands of lives daily, we at Tata Elxsi help global healthcare brands design, engineer, and commercialize differentiated and sustainable products for the competitive marketplace. Join our team of award-winning designers, technologists, and digital experts and craft your future. We are looking for a highly enthusiastic writer who has deep knowledge and rules in Medical Writing. Principal Duties and Responsibilities:

• This position requires an excellent resource that does the development of Clinical Evaluation Plans/Reports (CERs) and Post Marketing Reports with future additional for the development of other clinical evidence documents as part of the Medical Device Regulation (MDR) and Medical Device Directive (MDD)
• This is an excellent opportunity to grow your career and improve the quality of life for the people around you
• Author and conduct medical and technical writing of clinical evaluation reports (CERs) in support of compliance to EU MDR- Med Dev 2.7, rev 4 for devices across therapeutic areas
• Author and review post-market clinical follow-up (PMCF) plan and PMCF reports
• Summarize post-marketing surveillance and risk management data for the target device
• Work cross-functionally to ensure adherence to submission and company-driven deadlines
• Collaborate with stakeholders and participate in client calls and supporting work stream leaders
• Providing product guidance and expertise to conduct literature searches on products/product families
• Review the literature and interpret and summarize risks, alternate therapies and device-specific benefits from literature; collect and summarize primary data to support risk assessment
• Conduct proofreading, editing, document formatting, review comment integration, and document completion/approval activities
• Support senior writers to prepare regulatory documents that meet client expectations in terms of content, quality, and presentation

Expected areas of competence (i.e., knowledge, skills, and abilities)

• Exemplary knowledge of clinical evaluation processes and medical device development
• Ability to understand and interpret complex clinical data
• Strong, concise scientific style of writing with a high level of attention to detail
• Demonstrated strong writing and communication skills
• Ability to function well as a member of the team and build relationships between Clinical Affairs and other areas of the organization
• Proven analytical and negotiation skills
• Intermediate computer skills, including Microsoft Office Suite
• Ability to lead a team and influence others
• Proficient knowledge of EU regulations (MDR/MDD) and regulations outside of the EU.

Job location:- Pune Qualification - B.E, B.Tech, MCA, M.E, M.Tech Job Code - HLSBU-1117