Senior Clinical Evaluation Medical Writer at Medtronic

Hyderabad, Telangana, India

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, HealthcareIndustries

Requirements

B.E. or B.Tech in Mechanical/Biomedical Engineering
Minimum 6-8 years of quality engineering experience or equivalence and overall 8-12 years of experience
Understanding of CER, post-market surveillance processes and adverse event reporting
Familiar with ISO 9001, ISO 13485, ISO 14971, 21 CFR part 820, 21 CFR part 11, EU MDR and product specific industry standards
Familiar with DMAIC or DMADV (DFSS) methodologies
Good verbal and written communication skills including plan/report development
Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, and the Medical Device Regulation
Knowledge of risk management principles and hazard analysis in the context of medical devices
Familiar with Literature review, PMCF, IMDRF coding, CAPA and NCMR
Familiar with ISO 13485, ISO 14971 and EU MDR and product specific industry standards
Knowledge of product areas, current developments, and keeping abreast of current literature

Responsibilities

Writing, editing and reviewing regulatory documents (e.g., Clinical Evaluation Reports/clinical study reports/summaries/Summary of Safety and Clinical Performance/Periodic Safety Update Report) and responses to Notified Bodies
Writing and editing manuscripts or abstracts on clinical studies and/or scientific reports including special summaries from raw data for submission to regulatory agencies or for in-company use, monographs, comprehensive reviews, scientific exhibits and other projects requiring skill in medical communication
Collaborating with cross-functional team members daily, providing solution-oriented recommendations and gathering/analyzing data related to the performance and safety of medical devices
Partnering with regulatory affairs and medical experts to ensure accurate and timely submission of PSURs to regulatory authorities
Continuously monitoring and staying updated with evolving safety regulations and guidelines to ensure PSUR compliance
Conducting Post Market Surveillance activities (monthly literature review of products)
Conducting proofreading, editing, document formatting, review comment integration and document completion/approval activities
Seeking out and engaging regularly with peers, creating an environment of exchange and learning, and openly sharing successes and failures to promote collective learning
Administering applicable databases for activities related to the evaluation of clinical data, Clinical Evaluation reports and Post Market surveillance reporting
Preparing literature for new products and revising existing literature
Preparing responses regarding company products, drugs, or diseases and referring in-depth technical inquiries to medical personnel
Demonstrating ability to effectively play multiple roles on a cross-functional team including contributor, subject matter expert, leader, facilitator
Formulating, delivering and/or managing projects assigned and working with other stakeholders to achieve desired results; may act as a mentor to colleagues or direct the work of lower level professionals

Skills

Clinical Evaluation Reports

PSUR

CER

SSCP

Literature Review

PMCF

IMDRF Coding

CAPA

NCMR

Post Market Surveillance

Regulatory Writing

Medical Writing

Proofreading

Editing

Medtronic

Develops and manufactures medical devices and therapies

About Medtronic

Medtronic provides medical technology, services, and solutions to improve patient care. The company develops a variety of medical devices, including pacemakers, insulin pumps, surgical tools, and neurostimulation devices, which help diagnose, prevent, and treat chronic diseases. These products are used by hospitals, clinics, and healthcare professionals around the world. Medtronic stands out from competitors by investing significantly in research and development to create new products and offering additional services like training and patient management programs. The goal of Medtronic is to enhance patient outcomes and lower healthcare costs through its comprehensive range of medical solutions.

Fridley, MinnesotaHeadquarters

1949Year Founded

$3.2MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Sick Leave

Paid Holidays

401(k) Retirement Plan

401(k) Company Match

Employee Stock Purchase Plan

Employee Assistance Program

Wellness Program

Risks

Emerging competitors like Fire1 threaten Medtronic's heart failure management market share.

Spine biologics market growth may attract new entrants, increasing competition for Medtronic.

Recent IPOs in medtech indicate rising competition, challenging Medtronic's market position.

Differentiation

Medtronic's diverse product range spans cardiovascular, diabetes, neurological, and surgical technologies.

The company invests heavily in R&D to drive innovation in medical devices.

Medtronic offers comprehensive services, including training and technical support, enhancing product value.

Upsides

Exclusive deal with Kuros enhances Medtronic's orthopedic portfolio and market share.

Growing spine biologics market offers expansion opportunities in spinal fusion and regenerative medicine.

Balloon catheters market growth aligns with Medtronic's recent product launches, boosting cardiovascular presence.

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