Neujin Solutions Hiring Regulatory Affairs Consultant 2026: Exciting Career Opportunity in Medical Devices & IVD Industry

The medical devices and In Vitro Diagnostic (IVD) sector continues to experience significant growth across India and global markets. With increasing regulatory requirements and stricter compliance standards, organizations are actively seeking skilled professionals who can help navigate complex regulatory frameworks.

If you have experience in Regulatory Affairs (RA), Quality Assurance (QA), or Medical Device Manufacturing and are looking for a rewarding career move, this latest opportunity from Neujin Solutions Pvt. Ltd. may be worth considering.

The company is currently hiring for the position of Regulatory Affairs Consultant / Senior Regulatory Affairs Consultant at its Vadodara office. This role offers professionals an opportunity to work closely with medical device and IVD manufacturers while contributing to regulatory compliance, product approvals, and global market access initiatives.

Let’s explore the complete details regarding eligibility criteria, responsibilities, required skills, and application process.

About Neujin Solutions

Neujin Solutions Pvt. Ltd. is known for providing regulatory, compliance, and strategic consulting services to organizations operating in the healthcare, medical device, and diagnostics sectors.

The company supports manufacturers in meeting national and international regulatory requirements while ensuring product quality, safety, and compliance. Through its expertise in regulatory strategy, documentation, submissions, and quality management systems, Neujin Solutions helps businesses successfully launch and maintain products across multiple markets.

Professionals joining the organization gain exposure to diverse projects, international standards, and evolving healthcare regulations.

Job Details

Position Information

Particulars	Details
Company Name	Neujin Solutions Pvt. Ltd.
Position	Regulatory Affairs Consultant / Senior Regulatory Affairs Consultant
Location	Vadodara, Gujarat
Experience Required	3–5 Years
Employment Type	Full-Time
Industry	Medical Devices / IVD Devices
Department	Regulatory Affairs

This opportunity is ideal for experienced professionals seeking to advance their careers within the regulatory and compliance landscape of the medical device industry.

Why Regulatory Affairs Professionals Are in High Demand

The healthcare industry is heavily regulated to ensure patient safety and product effectiveness. Regulatory Affairs professionals play a crucial role in ensuring that medical devices and diagnostic products comply with national and international standards.

Their responsibilities often include:

Preparing regulatory submissions
Managing product registrations
Maintaining compliance documentation
Monitoring regulatory updates
Coordinating with regulatory authorities
Supporting product approvals

As regulatory frameworks such as EU MDR, EU IVDR, ISO 13485, and CDSCO requirements continue to evolve, companies increasingly rely on experienced professionals to guide them through compliance processes.

This growing demand makes Regulatory Affairs one of the most promising career paths within the medical device and healthcare sectors.

Educational Qualification Required

Candidates applying for this position should possess a bachelor’s degree in one of the following disciplines:

Preferred Educational Backgrounds

Biomedical Engineering
Mechanical Engineering
Electrical Engineering
Biotechnology
Other related scientific or technical disciplines

Applicants with relevant educational qualifications combined with practical industry exposure will be given preference during the selection process.

Experience Requirements

One of the most important aspects of this hiring announcement is the experience requirement.

Mandatory Experience

Candidates must possess:

3 to 5 years of relevant professional experience
Experience in Regulatory Affairs (RA)
Experience in Quality Assurance (QA)
Experience in Design and Development functions
Exposure to Medical Device Manufacturing
Experience within IVD manufacturing organizations

Important Eligibility Note

The company specifically seeks professionals who have worked directly within manufacturing environments.

Candidates whose experience comes solely from consultancy firms may not be considered suitable for this position.

Additionally:

❌ Freshers are not eligible

❌ Candidates without manufacturing experience may not qualify

✔ Manufacturing industry professionals with regulatory exposure are preferred

This requirement highlights the company’s focus on practical, hands-on industry knowledge rather than purely advisory experience.

Key Responsibilities

Professionals selected for the role will be entrusted with several critical responsibilities involving regulatory compliance, product registrations, and strategic guidance.

1. Regulatory Strategy and Guidance

The consultant will provide expert regulatory support to clients involved in manufacturing medical devices and IVD products.

Responsibilities include:

Advising clients on applicable regulations
Developing compliance strategies
Identifying regulatory pathways
Supporting market-entry plans

The role requires balancing regulatory requirements with practical business objectives.

2. Regulatory Documentation and Submission Management

One of the core responsibilities involves preparing and managing regulatory submissions.

Tasks may include:

Technical dossier preparation
Regulatory file compilation
Submission review
Documentation updates
Product registration support

Candidates should possess strong technical writing capabilities and attention to detail.

3. Managing Domestic and International Regulatory Approvals

The selected professional will assist in submissions to various regulatory authorities.

This may include:

CDSCO submissions
International regulatory registrations
CE marking documentation
USFDA-related regulatory support
Global compliance requirements

Knowledge of international regulatory systems will be highly beneficial.

4. Coordination with Regulatory Authorities

Regulatory Affairs professionals frequently serve as a bridge between manufacturers and regulatory agencies.

Key activities include:

Responding to authority queries
Managing technical communications
Tracking submission progress
Coordinating approval processes
Facilitating regulatory inspections

Strong communication and negotiation skills are essential for success in this area.

5. Compliance Maintenance

Regulatory compliance does not end after product approval.

The consultant will help clients maintain compliance throughout the product lifecycle by:

Monitoring ongoing regulatory requirements
Reviewing change controls
Updating technical files
Supporting audits
Ensuring continuous compliance

This responsibility ensures that products remain compliant even as regulations evolve.

6. Regulatory Intelligence Activities

Healthcare regulations constantly change across different regions.

The selected candidate will:

Track regulatory updates
Monitor emerging standards
Analyze regulatory changes
Inform stakeholders about compliance impacts
Recommend implementation strategies

This proactive approach helps organizations avoid compliance risks.

Skills Required for Success

Apart from technical qualifications and industry experience, Neujin Solutions is looking for candidates possessing several important competencies.

Strong Regulatory Knowledge

Applicants should understand:

Medical device regulations
IVD regulations
Regulatory pathways
Quality management systems
Product registration requirements

Knowledge of CDSCO, EU MDR, EU IVDR, and ISO standards will be valuable.

Excellent Communication Skills

Regulatory professionals spend a significant amount of time drafting and reviewing documents.

Strong abilities in:

Technical writing
Documentation
Professional communication
Client interactions
Regulatory correspondence

will contribute significantly to success in this role.

Analytical Thinking

Regulatory challenges often require innovative solutions.

Candidates should demonstrate:

Problem-solving abilities
Critical thinking
Risk assessment skills
Regulatory interpretation capabilities

These skills help organizations overcome compliance obstacles efficiently.

Project Management Skills

Consultants often work on multiple projects simultaneously.

Therefore, candidates should be comfortable with:

Managing deadlines
Prioritizing tasks
Handling multiple clients
Coordinating cross-functional teams

Effective time management will be a key success factor.

Team Collaboration

Although consultants frequently work independently, teamwork remains essential.

The role requires collaboration with:

Manufacturing teams
Quality departments
Design engineers
Regulatory authorities
Client organizations

Strong interpersonal skills can significantly enhance performance.

Understanding Key Regulatory Frameworks

Candidates applying for this position should ideally be familiar with major global regulatory systems.

ISO 13485

International Organization for Standardization ISO 13485 establishes requirements for quality management systems in medical device organizations.

It focuses on:

Product quality
Risk management
Process control
Regulatory compliance

Many global medical device manufacturers maintain ISO 13485 certification.

EU MDR

European Union Medical Device Regulation (EU MDR) represents one of the most comprehensive regulatory frameworks governing medical devices in Europe.

The regulation emphasizes:

Clinical evidence
Post-market surveillance
Risk management
Product safety

Understanding MDR requirements is highly valuable for regulatory professionals.

EU IVDR

European Union In Vitro Diagnostic Regulation (EU IVDR) governs diagnostic products marketed within Europe.

It introduces:

Stricter conformity assessments
Enhanced clinical evidence requirements
Greater oversight of diagnostic products

Professionals experienced with IVDR are increasingly sought after in the industry.

CDSCO Regulations

Central Drugs Standard Control Organisation serves as India’s national regulatory authority for pharmaceuticals and medical devices.

Medical device companies operating in India must comply with CDSCO regulations for product registrations and licensing.

Knowledge of Indian regulatory pathways remains essential for professionals in this field.

Benefits of Working at Neujin Solutions

Joining Neujin Solutions offers several professional advantages.

Exposure to Multiple Clients

Unlike traditional in-house regulatory roles, consultants often work across various organizations.

This provides:

Broader industry exposure
Diverse project experiences
Faster skill development
Enhanced professional growth

International Regulatory Experience

Professionals may gain hands-on exposure to:

US regulations
European regulations
Asian market requirements
Global submission strategies

Such experience can significantly strengthen a regulatory affairs career.

Learning and Development

The company promotes a culture of continuous learning.

Employees can enhance expertise in:

Emerging regulations
Global compliance frameworks
Quality systems
Regulatory strategy

Continuous learning remains critical in the rapidly evolving healthcare industry.

Career Advancement Opportunities

Experienced consultants often progress into roles such as:

Senior Regulatory Affairs Consultant
Regulatory Manager
Compliance Manager
Global Regulatory Lead
Quality and Regulatory Director

The knowledge gained through consulting can accelerate long-term career progression.

Who Should Apply?

This opportunity may be suitable for:

✔ Regulatory Affairs Professionals

✔ Medical Device Manufacturing Professionals

✔ IVD Industry Specialists

✔ Quality Assurance Professionals

✔ Design and Development Engineers

✔ Biomedical Engineers with Regulatory Experience

✔ Manufacturing Compliance Specialists

Candidates with strong manufacturing backgrounds and regulatory expertise will likely be the most competitive applicants.

How to Apply

Interested and eligible candidates can submit their updated resume directly to the recruitment team.

Email Application

Email ID: diksha.dayalwal@neujinsolutions.com

Recommended Subject Line

Application for Regulatory Affairs Consultant – Your Name – Years of Experience

For better visibility, candidates should ensure their resume highlights:

Manufacturing experience
Regulatory Affairs expertise
Quality Assurance exposure
Medical device knowledge
International regulatory experience
Relevant certifications

Including a concise cover letter explaining your experience and achievements can further strengthen your application.

Final Thoughts

The demand for skilled Regulatory Affairs professionals continues to rise as healthcare regulations become increasingly complex across global markets. The latest hiring initiative from Neujin Solutions presents an excellent opportunity for experienced professionals seeking growth within the medical device and IVD sectors.

With exposure to international regulatory frameworks, diverse client portfolios, and challenging compliance projects, this role can provide significant career advancement opportunities. Candidates possessing 3–5 years of manufacturing-based experience in Regulatory Affairs, Quality Assurance, or Design functions should strongly consider applying.

If you meet the eligibility criteria and are passionate about regulatory compliance, product approvals, and healthcare innovation, this Vadodara-based opportunity could be the next major step in your professional journey.