Maven Profcon Services LLP
Location
Ahmedabad | India
Job description
About Company:
We are Team MAVEN, the Medical Device Regulatory experts and the brilliance behind Maven Profcon Services LLP. We strive to foster innovative services that may contribute well to our customer's success. Our innovative passionate and result-driven professionals make MAVEN what it is today; providing modern approaches and remarkable service to clients all over the globe.
Our fairly performant team members possess vast expertise in regulatory consulting, auditing, medical device engineering, quality assurance, and virtual and commercial business intelligence, and many with medical device industry experience in technical fields. We develop and empower our staff to prosper to their fullest potential.
We believe in creating a healthy and competitive environment for our employees, which aids us in achieving higher productivity with robust and scalable solutions and assured results for our clients while also ensuring an optimal work/life balance. Our processes and selections are targeted to ensure that our auditors, trainers, and consultants have the resources and the means they require to deliver superior service to our clients.
About Role
Department: Quality Assurance/ Quality Management System
Roles and Responsibilities:
- Prepares, reviews, and/or maintains a range of other QA documentation as required
- Authors and reviews new and existing SOPs to further enhance and mature the Quality System.
- Evaluate and enhance departmental and company and/or vendor site quality procedures to ensure compliance with ISO 13485:2106
- Responsible for authoring and maintaining technical files for Europe as per EU MDR 2017/745
- Provides consultation/advice to manufacturing organizations for change control and product development.
- Provides regulatory direction/interpretation
- Interprets and applies regulatory understanding to support products and teams
- Ensure compliance with product postmarketing requirements
- Assembling PMS data for review and analysis
- Writing PMS reports and Periodic Safety Update Reports (PSUR)
- Involvement in the writing of Summaries of Safety and Clinical Performance (SSCP)
- Familiarity with the European MDR (EU Medical Device Regulation 2017/745)
- Conduct internal audits, identify CAPAs, and oversee the effectiveness of CAPA implementation to maintain site quality compliance
- Have a great knowledge of ISO 13485 and Medical Device legislation, to provide support and advice to the organization.
- Trains clients and other staff on regulatory compliance requirements and quality management system requirements
- Search various vigilance databases for adverse events and recalls.
Required Skills and Qualifications:
-Highly experienced professional in Medical Device Regulations
-Has experience in reviewing and preparing all QMS documents
-Has experience in Internal as well as external audits
-Relevant education relating to MDR
-2+ years of experience is mandatorily required in the QA area (Freshers do not apply)
Job location: Ahmedabad(On-site)
Salary: As per market standards
If you are a driven QA professional with a passion for ensuring compliance and driving the success of innovative medical devices, we invite you to apply for the above-mentioned position Maven Profcon Services LLP.
PoC
Payal Lotani (HR) - [HIDDEN TEXT]
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