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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

(Freshers can directly apply: no experience is required.)
Contact HR: +91 94299 52147

Maven Recruiting

  • Senior Regulatory Executive
  • Regulatory Affairs
  • Quality Assurance
  • Contract Management

Senior Regulatory Executive

The Senior Regulatory Executive will play a critical role in ensuring compliance with USFDA regulations for medical devices across all stages of product development, manufacturing, and post-market surveillance. The ideal candidate will possess a deep understanding of USFDA requirements, guidelines, and submission processes for medical devices, as well as a proven track record of successful interactions with regulatory authorities. The Senior Regulatory Executive will collaborate closely with cross-functional teams to drive regulatory strategies, lead regulatory submissions, and maintain compliance with changing regulatory requirements.

Experience Required: 2 – 5 years.

No. of open Positions: 3

Qualification other requirements:

  • MS-Regulatory affairs/Diploma in Regulatory Affairs/M Pharmacy/B. E Biomedical engineering/M.sc Biotechnology/M.sc Microbiology & graduation/post-graduation in any related scientific discipline
  • Proven track record of successful regulatory submissions and interactions with regulatory authorities, including USFDA.
  • In-depth knowledge of USFDA requirements, guidance documents, and submission processes for medical devices, including 510(k) notifications, PMAs, and IDEs.
  • Good understanding of international medical device regulations, such as EU MDR/IVDR, ISO 13485, and IEC 60601 will be an excellent add-on.
  • Excellent written and verbal communication skills, with the ability to effectively communicate complex regulatory concepts to diverse stakeholders.
  • Strong analytical and problem-solving skills, with a keen attention to detail.
  • Ability to work effectively in a fast-paced, dynamic environment and manage multiple priorities simultaneously.
  • Collaborative mindset with the ability to work cross-functionally and influence key stakeholders.

Roles and Responsibilities:

  • Prepare technical documentation for international regulations (USFDA) applicable to a wide range of medical devices on project basis.
  • Clinical evaluation writing
  • Gap analysis of client documentation and recommendation/working on changes
  • Communication with client on routine basis for project related information and data
  • Collect, review and integrate data in regulatory submissions.
  • Advise manufacturers on regulatory requirements when needed
  • Visit to Project site for understanding manufacturer’s practices to be integrated in the technical documentation
  • Attend to client queries, doubts and review comments
  • Audit client premises when required and also supporting client for certification audits
  • Keep up with updates in standards, guidelines and other regulatory requirements
  • Where needed support in preparation of training material and conducting training for various in-house, open-house, online and customized trainings requested by clients.
  • Develop and implement regulatory strategies to obtain and maintain USFDA approvals for medical devices, including pre-market clearance, 510(k) submissions, PMA applications, and IDE submissions.
  • Stay abreast of evolving USFDA regulations, guidelines, and industry best practices related to medical devices, and proactively communicate the impact of these changes to internal stakeholders.
  • Lead the preparation, review, and submission of high-quality regulatory documentation, including 510(k) notifications, technical files, design dossiers, and regulatory reports.
    • If you are a driven regulatory professional with a passion for ensuring compliance and driving the success of innovative medical devices in the US market, we invite you to apply for the position of Senior Regulatory Executive – USFDA (Medical Devices) at Maven Profcon Services LLP.

Regulatory Affairs

Experience: 0 – 5 Yrs.

Qualification: MS-Regulatory affairs, Diploma in Regulatory Affairs, M Pharmacy, B.E Biomedical engineering, M.sc Biotechnology, M.sc Microbiology & graduation/post-graduation in any related scientific discipline

Job Profile: As a Regulatory Affairs executive, you shall:

  • Prepare technical documentation for various national (Indian MDR) and international regulations (CE, USFDA, UKCA, Country registrations) applicable to a wide range of medical devices on project basis.
  • Clinical evaluation writing
  • Gap analysis of client documentation and recommendation/working on changes
  • Communication with client on routine basis for project related information and data
  • Collect, review and integrate data in regulatory submissions.
  • Advise manufacturers on regulatory requirements when needed
  • Visit to Project site for understanding manufacturer’s practices to be integrated in the technical documentation
  • Attend to client queries, doubts and review comments
  • Audit client premises when required and also supporting client for certification audits
  • Departmental activities, discussions and research for continual improvement
  • Keep up with updates in standards, guidelines and other regulatory requirements
  • Where needed support in preparation of training material and conducting training for various in-house, open-house, online and customized trainings requested by clients.

Quality Assurance

Experience: 0 – 5 Yrs.

Qualification: MS-Regulatory affairs, Diploma in Regulatory Affairs, M Pharmacy, B.E Biomedical engineering, M.sc Biotechnology, M.sc Microbiology & graduation/post-graduation in any related scientific discipline

Skills: Excellent communication, verbal, and writing skills, excellent planning, organization, and flexibility to adjust to a rapidly changing environment, strong attention to detail, ability to work independently and in a team environment, Proficient in Microsoft Excel, Word.

Job Profile: As a Quality Assurance Executive, you shall:

Quality Management System:

  • Prepare quality management system documentation as per standard requirements of ISO 9001, ISO 13485, 21 CFR Part 820, MDSAP, Integrated quality management system based on combination of aforementioned
  • Gap analysis of existing QMS documentation and recommendation/working on changes
  • Implementation of QMS within the clients’ premises and training employees in clients’ organization on how to adequately fill the formats and retain them
  • Communicate with client on routine basis for project related information and data
  • Collect, review and integrate data in documentation
  • Visit to Project site for understanding manufacturer’s practices to be integrated in the technical documentation and for implementation
  • Attend to client queries, doubts and review comments
  • Conduct initial Internal Quality Audit and Management Review Meeting at client premises and also support client for certification audits
  • Departmental activities, discussions and research for continual improvement
  • Keeping up with updates in standards, guidelines and other regulatory requirements
  • Where needed support in preparation of training material and conducting training for various in-house, open-house, online and customized trainings requested by clients.
  • Shall have basic knowledge of technical documentation of EU-MDR including risk management, clinical evaluation, post market surveillance.
  • Plans, organizes, and coordinates validation activities at the facilities. Write validation protocols and compile final reports.

Contract Management

Experience: 0 – 5 Yrs.

Qualification: MS-Regulatory affairs, Diploma in Regulatory Affairs, M Pharmacy, B.E Biomedical engineering, M.sc Biotechnology, M.sc Microbiology & graduation/post-graduation in any related scientific discipline

Job Profile: As a Contract Management – Executive, you shall:

  • Support implementation, development, maintenance and control of a quality management system according to international standards and corporate guidelines/policies/procedures and applicable regulations for certification held by the client
  • Prepare annual AMC calendar under the supervision of department head
  • Conduct Internal Quality Audit and Management Review Meeting at intervals defined in QMS of the client
  • Prepare and Support client for re-certification and surveillance audits
  • Ensure closure of non-conformities observed during such audits, verify implementation of such corrective actions, and maintain relevant evidence.
  • Maintaining clients technical documentation, assure an effective, consistent and reliable forward of information in terms of product surveillance
  • Visit client premises at frequency defined in the AMC calendar, support their routine activities, and provide appropriate guidance
  • Prepare monthly follow ups for Post market data and monthly status report with details of all activities performed for a specific AMC client
  • Prepare PMSR, PSUR, PMCF report, Analysis of data, on annual basis based on the data received from the client
  • Update MAUDE, MHRA and information retrieved from other databases along with Sales, complaint and audit data in the Clinical evaluation on annual basis
  • Update risk if any new hazards or hazardous situation are identified during routine production and post production activities
  • Review customer feedbacks, customer complaints, distributor agreements, supplier evaluation and re-evaluation, training records, quality objectives routine batch manufacturing records, calibration records, and preventive maintenance schedule.
  • Verify Corrective Action Reports against customer complaints and Internal Quality Audit.
  • Continuous communication with the client to address their concerns w.r.t scope of AMC

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