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Career Regulatory

Are you the one we are looking for?

We are inviting applications for associate and specialist in Regulatory affairs.
In this role, you will be expected to have the following attributes:

  • Work on deadlines
  • Highly professional
  • Excellent Microsoft Outlook, Excel, Word, and PPT skills
  • Basic knowledge of medical devices
  • English speaking, writing, and listening skills are highly desired
  • Attention to details
  • Individual contributor with minimal supervision
  • Enthusiasm to learn more and grow rapidly
  • Project coordination and work with multi-cultural teams
  • Highly confident and self-motivated
  • The optimistic and problem-solving thought process

Contact HR
Phone: +91 94299 52147
Email: payal.lotani@mavenprofserv.com

Maven Recruiting

  • Senior Quality Assurance Executive - Medical device
  • Technical Sales Executive

Senior Quality Assurance Executive - Medical device

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.

Quality Assurance/ Quality Management System

Experience Required: 2+ years of experience is mandatorily required in the QA area (Freshers do not apply)

No. of open Positions: 3

Offered Salary: AS PER MARKET STANDARDS

Required Skills and Qualifications:

  • Highly experienced professional in Medical Device Regulations/li>
  • Has experience in reviewing and preparing all QMS documents
  • Has experience in Internal as well as external audits
  • Relevant education relating to MDR

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.

Technical Sales Executive

Experience: 0 – 3 years of experience in sales (Service industry experience would be considered)

Qualification: A bachelor’s degree is a must in any relevant field (Bach. in Biomedical/Bach. in Pharma will be given first priority)

Exceptional Communication skills

Willing to relocate

SALARY OFFERED: AS PER MARKET STANDARDS

KEY RESPONSIBILITIES AREAS

Sales Revenue Generation: Meet or exceed sales targets and revenue goals by identifying and pursuing new business opportunities, upselling to existing customers, and closing deals.

Customer Relationship Management: Build and maintain strong relationships with key clients, understanding their needs and challenges, and providing effective solutions to enhance customer satisfaction and loyalty.

Technical Expertise: Develop a deep understanding of the products or services being offered and staying up to date with industry trends, competitor offerings, and technological advancements. Using technical knowledge to effectively communicate product features, benefits, and value propositions to customers.

Sales Strategy and Planning: Develop and execute sales strategies, including identifying target markets, creating sales plans, and implementing sales techniques to maximize revenue generation and market penetration.es, and providing effective solutions to enhance customer satisfaction and loyalty.

Sales Pipeline Management: Manage the sales pipeline by tracking and monitoring leads, opportunities, and deals at various stages of the sales process. Proactively managing and nurturing leads to ensure a healthy pipeline and a steady flow of potential customers.

Team Collaboration: Collaborate with cross-functional teams, such as marketing, and customer support, to ensure alignment in sales efforts, effective product positioning, and seamless customer experiences

Sales Reporting and Analysis: Generate regular reports on sales activities, performance, and market trends. Analysing data to identify areas of improvement, develop insights, and make data-driven decisions to optimize sales strategies and processes.

Continuous Learning and Development: Stay updated with industry knowledge, attending training sessions, conferences, and workshops to enhance product knowledge, sales techniques, and professional skills.

Outdoor Meetings: This role includes visiting the client location for finalization of deals. Also, setting up booths in national and international trade fairs to attract clients.

Join Our Team Now!

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