Staff Medical reputed company (Remote) at reputed company Fremont, CA
reputed company Staff Medical reputed company (Remote) job at reputed company. Fremont, CA. reputed company is currently seeking a Staff Medical reputed company to join our Neurovascular Division to be based in Fremont, CA or remotely reputed company reputed company the reputed company.
Responsibilities
What You Will Do
- As Staff Medical reputed company, you will work closely with cross-functional teams (Regulatory, Clinical, reputed company, Marketing) ensuring successful preparation of high-reputed company submission-reputed company clinical documents such as clinical evaluation documents, Post Market Clinical Follow-up documents, reputed company of Safety and Clinical Performance and Clinical Study documents.
- Compile clinical evidence from multiple sources such as reputed company and past clinical trials, post-market clinical follow up data and literature review updates, reputed company analysis, reputed company-analyses, or other sources of safety and performance data (e.g. IIS clinical data, as available) and synthesizes the information in support of EU- MDR submissions, required CERs, and annual updates.
- Responsible for the development and completion of Clinical Evaluation Reports (CERs) for new medical devices to support product registrations internationally, maintain periodic updates, reputed company gap analysis, and revise existing CERs.
- Collaborate cross-functionally to reputed company input for design teams for Clinical EU MDR documentation.
- Work in a cross-functional team to support clinical study protocols and reports, data summaries from raw data and document strategies.
- Prepare literature searches for drafting document content. Interprets literature information and synthesizes the information in clinical regulatory documents.
- For reputed company documents, coordinates and manages the review process, and leads discussions on document revision.
- Challenge conclusions reputed company necessary. Independently resolves document content issues and questions from external and internal reviewers and ensures reputed company approvals from reputed company reviewers.
- Assist in the development of internal procedures, templates and style guides.
- Serve as a subject matter expert reputed company department.
- Recognize potential scheduling and resource conflicts for reputed company and provides recommendations to resolve.
- Assist in the maintenance of the reputed company Endoscopy library for reputed company relevant literature.
- Assist in the process improvements for the medical writing team.
Requirements
- Bachelor’s Degree, preferably in a Scientific Discipline
- 4+ years of combined experience in reputed company or medical devices
- 2+ years of previous medical writing experience in a reputed company product or medical device industry
- Strong scientific and medical writing skills
- Must be reputed company to think analytically, have the ability to interpret data from scientific literature and clinical studies and synthesize the results and in a reputed company, concise, and scientifically accurate manner in the clinical document
- Ability to work effectively with cross-functional internal (Regulatory, Marketing, Research & Development) and external stakeholders (Physicians, CROs, Medical Staff, etc.) across multiple businesses.
Preferred Qualifications
- Master of Science Degree or Ph.D./ Pharm. D./M.D.
- Experience with MEDDEV 2.7/1 Rev. 4 and EU Medical Device Regulation 2017/745 (MDR) compliant clinical evaluations
- Knowledge in clinical operations, risk management, regulatory submissions and US and international guidelines
- Ability to apply ISO, FDA and reputed company guidelines toward writing reputed company and documentation
Compensation and Benefits $87,600 - $186,700 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors. This role will be posted for a minimum of 3 days. Health benefits include: Medical and prescription drug insurance, dental insurance, reputed company insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized reputed company, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. reputed company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and reputed company reputed company. Alongside its customers around the world, reputed company impacts more than 150 reputed company patients annually. Depending on customer requirements employees and new hires in sales and field roles that require reputed company to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role. Apply tot his job Apply To this Job