Ivd Regulatory Writer

2 weeks ago

Hyderabad, India Cyient Full time

Cyient is a global engineering and technology solutions company. As a Design, Build, and Maintain partner for leading organizations worldwide, we take solution ownership across the value chain to help clients focus on their core, innovate, and stay ahead of the curve. We leverage digital technologies, advanced analytics capabilities, and our domain knowledge and technical expertise, to solve complex business problems.

With over 15,000 employees globally, we partner with clients to operate as part of their extended team in ways that best suit their organization’s culture and requirements. Our industry focus includes aerospace and defence, healthcare, telecommunications, rail transportation, semiconductor, geospatial, industrial, and energy.

**Job Description**:

- Under general supervision, responsible for writing technical copy for various operation and maintenance manuals and technical publications.
- Prepares written text and coordinates layout and organization of manuals and other documents according to prepared outlines and specifications.
- Researches available technical data including drawings, design reports, equipment, and test specifications.
- May work with engineers and other technical personnel to clarify document contents.
- Preparation and writing of Technical Documentation for in vitro diagnostic medical devices in compliance with IVDR and internal procedures.
- Writing the Instruction for Use in accordance with IVDR requirements and internal procedures.
- Ensure product labels meet the IVDR requirements and internal procedures.
- Contribute to risk management activities.
- Review and provide regulatory inputs to critical deliverables for technical documentation (Post-Market Surveillance Plan, Risk management Plan, Risk analysis, Risk management report, Performance evaluation plan and report, Analytical and Clinical performance reports, Design and manufacturing documentation).
- Support the gap analysis of new/updated regulatory guidance related to IVDR.
- Manage the follow up of the registration procedures and preparation of responses to the Notified Body.

Skills & Experience

ISO 13485 Medical Devices, Quality Control, - Clinical/ medical writing /regulatory writing experience - FDA (510K) submissions - Excellent communication skills both written and verbal

Cyient is an Equal Opportunity Employer.

Cyient recruits, employs, trains, compensates, and promotes regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, veteran status, and other protected status as required by applicable law. We are proud to be a diverse and inclusive company where our people can focus their whole self on solving problems that matter.

  • Regulatory Writer

    5 days ago

    Bengaluru, Chennai, Hyderabad, India Primus Global Technologies Full time ₹ 12,00,000 - ₹ 25,00,000 per year

    Please find the JD attached below for your reference.Position Scientific Writer / Regulatory WritingExperience- 3-5 Years Sr. Associate/ 7-9 Years – Lead / 10+ years- Associate ManagerLocation- Bang, Hyd, Mumbai, Pune, Delhi NCR (Hybrid-2 day WFO) Full time positionJob Description –Regulatory Writing / Medical Writer :The Scientific and Medical content...

  • Expert Regulatory Writer

    6 days ago

    Hyderabad, India Novartis Full time

    500! The number of regulatory documents we authored last year. As an Expert Regulatory Writer you will develop documents which cover all Novartis therapeutic areas and therapies, ranging from Phase I to IV Clinical Study Reports to regulatory submission documents (e.g. Clinical Summaries, Clinical Overview, Briefing Books, answers to Health Authority...

  • Regulatory Writer

    2 weeks ago

    Hyderabad, India Novartis Full time

    900! That is the approximate number of individual regulatory documents the dynamic team at Regulatory Writing and Submissions (RWS) planned, developed and wrote. And that’s just in 2019! Come, join a global team of nearly 200 regulatory professionals - life scientists, clinicians and project managers across 6 countries and support Novartis in its mission...

  • Senior Medical Regulatory Writer

    1 week ago

    Hyderabad, Telangana, India Opella Full time ₹ 12,00,000 - ₹ 24,00,000 per year

    Job title: Senior Medical Regulatory WriterLocation: HyderabadOpella is the self-care challenger with the purest and third-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally.​Our mission: to bring health in people's hands by making self-care as simple as it should be for over half a billion consumers...

  • Associate Regulatory Affairs

    1 week ago

    Madhapur, Hyderabad, Telangana, India Makrocare Full time

    Company Description **MakroCare |** **_A MakroGroup Company_**- MakroCare is an Expert Strategic Development and Commercialization Global Partner for the Pharmaceutical, Biotechnology and Medical Device industries. Our Experience, Programs and Processes bring a New Dimension to Development Strategy, Regulatory/Risk Planning & Management, Clinical Research,...

  • Scientific / regulatory content writer

    4 weeks ago

    Hyderabad, India ArtiXio Full time

    About the RoleWe are seeking a Scientific / Regulatory Content Writer with 4–7 years of proven experience in developing high-quality content in the scientific, medical, or regulatory domains. The ideal candidate will have exceptional writing skills, a keen eye for detail, and the ability to transform complex topics into clear, engaging, and evidence-based...

  • Sr. Associate Regulatory Affairs

    2 days ago

    Hyderabad, Telangana, India Amgen Inc Full time ₹ 20,00,000 - ₹ 25,00,000 per year

    Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Amgens CMC submission execution team, Regulatory...

  • Sr. Associate Regulatory Affairs

    2 weeks ago

    Hyderabad, Telangana, India Amgen Full time ₹ 12,00,000 - ₹ 24,00,000 per year

    Career CategoryRegulatoryJob Description Job Description:Amgen is a leading human therapeutics company in the biotechnology industry.  For more than 40 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine.  As a Fortune 500 company serving millions of patients, Amgen continues to be an...

  • Medical Writer

    3 weeks ago

    Hyderabad, India ValueLabs Full time

    Job descriptionThe Medical Writer will be responsible for preparing high-quality clinical, regulatory, and scientific documents that support drug development and regulatory submissions.Experience : 1+ yearsLocation : Hyderabad (Work from office)Roles & Responsibilities:Draft, review, and finalize clinical study protocols, investigator brochures, informed...

  • Medical Writer

    4 weeks ago

    Hyderabad, India ValueLabs Full time

    Job descriptionThe Medical Writer will be responsible for preparing high-quality clinical, regulatory, and scientific documents that support drug development and regulatory submissions.Experience : 1+ yearsLocation : Hyderabad (Work from office)Roles & Responsibilities:Draft, review, and finalize clinical study protocols, investigator brochures, informed...