CER Technical Writer

Remote in Raynham, MA, US • Posted 4 days ago • Updated 1 hour ago

Contract W2

On-site

Motion Recruitment Partners, LLC

Fitment

Dice Job Match Score™

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Job Details

Skills

Writing
Quality Management
Management
Effective Communication
Microsoft SSRS
Surveillance
Research and Development
Regulatory Affairs
Business Analytics
Business Analysis
Evaluation
Regulatory Compliance
Reporting
Medical Devices
Risk Management
Auditing

Summary

CER Technical Writer - Remote
The CER Technical Writer must have experience within the medical device industry and knowledge of clinical evaluation report regulatory requirements, evidence generation, and CER document creation to be considered. This is a remote position to work out of your home office full time.

Responsibilities:

Responsible for the writing of Clinical Evaluation Plans
Responsible for compliant writing of Clinical Evaluation Reports within this business in accordance to local procedures, the client's guidelines and regulatory requirements
Responsible for ensuring compliant creation of SSR reports within this business in accordance to local procedures, the client's guidelines and regulatory requirements
Ensures the CER and SSR files are linked to appropriate Quality Systems and Regulatory documents (e.g. Risk Management, PMS, etc.) to make certain information is consistent and accessible where needed. S/He will develop, implement and manage an effective communication model for CERs/SSRs with cross functional business partners
Assists in the development of schedules to ensure operating company CER/SSR timelines are met
Participates in workshops and on initiatives to help define processes globally and keep abreast of CER regulatory requirements and industry trends/practices, ensuring that a proactive ongoing review of processes and procedures is in place to maintain a strong regulatory profile while continually improving process efficiencies
Supports and at times acts as an SME during audits and inspections pertaining to CER/SSR processes and reports.
Will actively partner with cross-functional business partners such as Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs relating to the CER/SSR process

Education & Experience:

BA, BS, or BSN is required; advanced degree is preferred
A minimum of 2 years of related job experience is required for this position
Experience within the medical device industry and knowledge of clinical evaluation report regulatory requirements, evidence generation, and CER document creation is required
Demonstrated knowledge and experience in quality regulatory compliance, complaint handling, adverse event reporting, medical device risk management processes, and experience with common bio statistical methods is preferred
Regulatory/Notified Body audit experience is preferred

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 10105282
Position Id: 864612
Posted 4 days ago

Company Info

About Motion Recruitment Partners, LLC

Motion Recruitment delivers IT Talent Solutions for Contract, Direct Hire, Managed Solutions and Statement of Work to all of North America from our 21 delivery centers. Our high-touch, specialized, team-based recruitment model’s success is proven through our exemplary track record in filling the most challenging IT positions for startup and enterprise clients alike. Our hyper-specialized tech focus results in a truly consultative approach for both our clients and candidates, within our recruiting areas of expertise: Software, Mobile, Data, Infrastructure, Cybersecurity, Product + UX and Functional.

Motion also delivers IT Consulting Solutions through the Motion Consulting Group (MCG) that create true digital transformation for IT projects in Agile Development & Coaching, DevOps & DevSecOps Solutions, and Managed Services for IT Operations.

We’re also the proud creators of Tech in Motion and the Timmy Awards, our North American community platform, events series and award program that connects over 250,000 tech enthusiasts to meet, learn, and innovate.

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