Job Description

Roles & Responsibilities Ensure on-time development and delivery of various sections of high-quality regulatory documents compliant with MEDDEV 2.7/1 Rev. 4. and MDR for Medical Devices across therapeutic areas Actively engage with internal stakeholders and cross-functional client business teams such as Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs Deliver solutions that are customized per client requirements in terms of language, content, format, and presentation Assist the Team Lead/Manager in the development of schedules to ensure timely delivery Manage timelines and communicate with team members to maintain awareness of expectations, milestones, and deliverables Train and mentor junior members of the team on technical/process related aspects Conduct proofreading, editing, document formatting, review comment incorporation and document completion / approval activities Perform literature searches on various databases Screening, appraisal per pre-defined criteria, and summarization of articles Interpret and present data from device-specific technical documents such as User Manuals/Instructions for Use Summarize quantitative data from post-marketing surveillance Conduct editing, proofreading, document formatting, and other document completion/approval activities Education Bachelors Degree / Post Graduation in any relevant Life Sciences field. Masters Degree is preferred. Experience Publication experience in scientific journals preferable Minimum 3 years of experience in Medical Device Regulatory documentation Familiarity with the Life Sciences Industry, preferably Regulatory Services Hands on experience on CEP/CER/PMSR/PSUR process Experience in creating high quality deliverables for customers Experience in handling projects and engaging with multiple clients independently Experience of working on projects involving all devices classes from various Therapeutic Areas Technical/Functional Skills Knowledge of clinical evaluation and related documents and regulatory requirements Proficiency in comprehension of scientific data and medical terminology and efficiency in summarizing information from source documents and published literature Proficiency with Microsoft Office (Word, Excel, and Outlook) Hands on experience on presentation tools such as PowerPoint, Visio etc., and referencing tools such as Zotero, Endnote, etc. will be an added advantage Effective reviewing skills for review of work done by trainees/junior writers Non-Technical Skills Strong verbal and written communications skills Ability to work as part of a team A constant zeal towards learning and skill development Potential to multitask and work within timelines Ability to understand and deliver on customer requirements Mentoring skills to act as trainer/mentor for junior members of the team Personal Traits Positive Attitude Initiative and Commitment Detail Oriented Team player Focused and sincere Perseverance Competencies Basic English grammar, punctuation, and sentence construction Logical comprehension Knowledge of medical terminology Excellent Communication (Writing and Verbal) Quality focused mindset Good time management Good stakeholder management