Maven Profcon Services LLP has announced hiring for two Medical Device Regulatory Affairs and Quality Assurance positions in Ahmedabad, Gujarat. The openings are for Regulatory Executive – Medical Device CDSCO and Senior Executive – QA & AMC.

These opportunities are suitable for experienced candidates from Pharmacy, Life Sciences, Biotechnology, Biomedical Engineering, Regulatory Affairs, Quality Management and related disciplines who want to build their careers in medical device regulatory affairs, CDSCO compliance, Quality Management Systems (QMS) and regulatory consulting.

Candidates with hands-on experience in CDSCO medical device submissions, Medical Device Rules (MDR) 2017, ISO 13485, QMS, CAPA, internal audits and medical device regulatory compliance may find these roles particularly relevant.

Vacancy Details

*The detailed job description mentions 2–4 years, while the employer’s hiring note states 1–3 years. Candidates within the relevant experience range can consider applying, particularly if they have hands-on CDSCO medical device submission experience.

1. Regulatory Executive – Medical Device CDSCO

The Regulatory Executive – CDSCO position focuses on Indian medical device regulatory submissions, registrations, licensing and compliance under the Medical Device Rules (MDR), 2017.

Candidates should have practical experience working with CDSCO regulatory submissions and understand the regulatory pathway for medical devices in India.

Key Responsibilities

• Prepare, review and maintain medical device regulatory documentation according to MDR 2017 and CDSCO guidelines.
• Compile and submit applications for medical device registrations.
• Handle manufacturing licence and import licence documentation.
• Submit regulatory applications through the CDSCO online portal.
• Coordinate with clients and internal teams to collect required regulatory documents.
• Review and validate documents before regulatory submission.
• Track regulatory submission timelines and approval status.
• Prepare responses to CDSCO regulatory queries and deficiency letters.
• Interpret Indian medical device regulations and provide regulatory guidance.
• Assist with technical documentation and labelling reviews.
• Prepare declarations and other compliance documentation.
• Support licence amendments, renewals and regulatory change notifications.
• Monitor updates to CDSCO regulations, MDR 2017 and applicable Indian standards.
• Coordinate with project teams to maintain regulatory compliance throughout the medical device product lifecycle.
• Maintain regulatory records according to applicable quality management requirements.

Qualification

Candidates with a Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Biomedical Engineering, Biotechnology or a related discipline can apply.

Relevant degrees may include:

B.Pharm / M.Pharm / B.Sc / M.Sc Life Sciences / Biotechnology / Biomedical Engineering / related qualifications

Experience Required

The employer’s hiring announcement specifies 1–3 years of experience, while the detailed qualification section mentions 2–4 years of Medical Device Regulatory Affairs experience.

Most importantly, candidates should have:

• Hands-on Medical Device Regulatory Affairs experience.
• Practical experience with CDSCO medical device submissions.
• Knowledge of Medical Device Rules (MDR), 2017.
• Knowledge of the CDSCO online portal.
• Understanding of medical device classification and licensing.
• Knowledge of Indian medical device regulatory frameworks.
• Familiarity with ISO 13485 and ISO 14971 is an added advantage.
• Strong regulatory documentation and communication skills.

Medical Device Regulatory experience is mandatory for this position.

2. Senior Executive – QA & AMC

The Senior Executive – QA & AMC position is focused on medical device Quality Management Systems, client projects, audits, CAPA management, technical documentation and AMC activities.

This is a more experienced position requiring candidates who can independently manage projects, client communication and team responsibilities.

Key Responsibilities

• Manage implementation and maintenance of Quality Management Systems.
• Execute QMS and AMC activities for clients.
• Review and approve SOPs and other QMS documentation.
• Review Design Files and technical documentation.
• Review validation and stability study documentation.
• Review TCFs and country registration documents.
• Conduct and manage Internal Quality Audits (IQA).
• Coordinate Management Review Meetings (MRM).
• Review audit corrective action reports.
• Manage NC/OFI closure and corrective actions.
• Handle CAPA and quality-related activities.
• Plan and monitor AMC activities and annual performance reviews.
• Manage client communication, meetings and site visits.
• Resolve technical and regulatory client queries.
• Allocate projects and tasks to team members.
• Guide junior employees and interns.
• Conduct client induction and on-the-job training.
• Monitor team competency and KPIs.
• Track project and departmental performance.
• Identify process improvement and automation opportunities.
• Conduct technical interviews and support competency development.

Qualification

Candidates with a Bachelor’s or Master’s degree in Biomedical Engineering, Biotechnology, Life Sciences, Pharmacy, Regulatory Affairs, Quality Management or another relevant discipline can apply.

Relevant qualifications may include:

B.Pharm / M.Pharm / B.Sc / M.Sc Life Sciences / Biotechnology / Biomedical Engineering / Regulatory Affairs / Quality Management

Experience Required

Candidates should have 3+ years of relevant experience in areas such as:

• Quality Assurance / QMS
• Medical Device Regulatory Affairs
• AMC
• Regulatory consulting
• Medical device consultancy

Experience in medical device consultancy is mandatory.

Required Skills

Candidates should have strong knowledge of:

• ISO 13485
• Quality Management Systems (QMS)
• Internal Quality Audits
• CAPA
• Non-Conformance (NC) management
• Management Review Meetings (MRM)
• Technical documentation
• Medical device quality systems
• Regulatory compliance
• Client management
• Project management

Strong analytical, documentation, communication and team-management capabilities are also expected.

Why Consider These Opportunities?

These Maven Profcon Services LLP jobs can provide experienced professionals with exposure to several important areas of the medical device industry, including:

• Medical Device Regulatory Affairs
• CDSCO submissions and licensing
• Medical Device Rules 2017
• Quality Management Systems
• ISO 13485
• Regulatory documentation
• CAPA and audit management
• Client-facing regulatory consulting
• Post-approval regulatory activities
• Medical device lifecycle compliance

The roles can be particularly relevant for professionals planning long-term careers in Medical Device Regulatory Affairs, QA/QMS, Regulatory Compliance or Medical Device Consulting.

Who Should Apply?

For the Regulatory Executive – CDSCO position, candidates should primarily have hands-on experience with medical device CDSCO submissions and Indian medical device regulations.

For the Senior Executive – QA & AMC position, candidates should have at least 3 years of relevant QA/QMS, regulatory or medical device consultancy experience, along with strong knowledge of ISO 13485 and quality systems.

These positions are not primarily fresher openings, as relevant industry experience is specifically requested.

How to Apply

Application Link For Senior Executive – QA & AMC

Application Link For Regulatory Executive – Medical Device CDSCO