• Medical Devices-Regulatory

Industry IT
Location Chennai
Experience Range 2 - 8 Years
Qualification BTECH (MTECH) B.Sc (MSCs)
Expired

Functional Medical Professional / Healthcare Practitioner / Technician
Job Description
About Us
With a presence in 12+ locations pan India, V5 Global is one of the leading manpower providers with 15,000+ associates across service lines of SalesForce, Merchandising, Audit, Retail Marketing Solutions delivered on along with CRM and Mobile application platforms. We provide the best-in-industry HR environment to attract and retain talent. V5 Global has an array of blue chip clientele, comprising more than 40 Multinationals companies and is also substantiated by demonstrated expertise across multiple sectors. Our growing client roster continues to give us the opportunity to learn from our collaborators every day. We look at every new project as a chance to grow, to challenge ourselves, to give our clients more than they ask for, and to push the boundaries of what’s possible.
About Company
www.v5global.com
Roles and Responsibility

Skill: Medical Devices-Regulatory

Experience: 2.5 - 5 Years

Location: Chennai -WFH

 

Identification of applicable regulatory standards and requirements for said Medical devices

Preparation of sufficient supporting documentation to support regulatory compliance requirements

Learns and applies standard, policies, practices, techniques, analytical and statistical tools

Support in preparing and compiling of Technical documents, DMR/DHF for regulatory submission

Hands-on/knowledge on ISO 13485, ISO 14971, EU MDR

Understanding on MEDDEV 2.7/1 Rev 4, Notified bodies expectations from Clinical evaluation

 

(1.)  To identify and independently implement product standards and regulatory requirements (with the cross functional product development teams) in compliance to target market or country's product compliance regulations

(2.)  To participate in product design discussions (pre-design and post-implementation phase of the product) with cross functional development teams to ensure that all product global standards and product regulatory compliances are incorporated and strictly adhered to

(3.)  To prepare the assigned product's technical documents validating product regulatory compliance as per the markets' laws and norms

(4.)  To participate in product standards and regulations compliance internal audits or reviews of the assigned product and make necessary modifications as required; and, also participate in accredited external Compliance test audits for each of the identified product's target market

(5.)  To provide necessary support post release of the product for customers and clients and make any regulatory modifications as suggested by supervisor

 

 

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