Regulatory Specialist Job SI Surgical Pvt Ltd Howrah. Apply online for regulatory affairs role with ISO, CE, BIS certification experience.
Introduction
Professionals with experience in regulatory affairs and quality compliance have a new opportunity to advance their careers in the medical device industry. SI Surgical Pvt Ltd is currently looking for an experienced Regulatory Specialist who can manage certification processes, regulatory documentation, and compliance systems.
This role offers an excellent platform for candidates who have worked with ISO standards, CE marking, and BIS certification and want to contribute to maintaining global regulatory standards within a growing healthcare manufacturing organization. The position involves collaboration with internal departments, coordination with certification bodies, and continuous improvement of regulatory processes. Regulatory Specialist Job SI Surgical
Company Overview
SI Surgical Pvt Ltd is a healthcare manufacturing company involved in the development and supply of medical and surgical products. The organization focuses on maintaining strict quality and regulatory standards to ensure that its products meet both Indian and international compliance requirements.
With increasing global regulatory expectations in the healthcare and medical device sector, companies like SI Surgical invest heavily in quality management systems, certification procedures, and regulatory compliance frameworks. Professionals working in regulatory affairs play a critical role in ensuring that products adhere to industry standards and safety regulations. Regulatory Specialist Job SI Surgical
Job Overview
| Job Details | Information |
|---|---|
| Company Name | SI Surgical Pvt Ltd |
| Position | Regulatory Specialist |
| Industry | Medical Devices / Healthcare Manufacturing |
| Location | Howrah, West Bengal, India |
| Experience Required | 3 – 5 Years |
| Qualification | Bachelor’s Degree |
| Salary | ₹20,000 – ₹25,000 per month |
| Application Mode | Online Application |
| Employment Type | Full-Time |
| Category | Regulatory Affairs / Quality Compliance |
Job Location & Employment Type
The Regulatory Specialist role is based in Howrah, West Bengal, where the candidate will work closely with compliance, quality, and production teams.
This is a full-time position involving regulatory coordination, certification management, documentation control, and audit preparation within the medical device manufacturing environment.
Professionals in this role typically work in office-based regulatory departments but may also participate in audits and certification inspections when required. Regulatory Specialist Job SI Surgical
Open Position / Department
Position: Regulatory Specialist
Department: Regulatory Affairs / Quality Compliance
The regulatory affairs department plays an important role in ensuring that products and processes meet national and international quality standards. The Regulatory Specialist will be responsible for supporting certification programs and maintaining compliance systems across various regulatory frameworks. Regulatory Specialist Job SI Surgical
Key Roles and Responsibilities
ISO Certification Coordination
The selected candidate will support the management and implementation of ISO certification programs within the organization. This includes maintaining compliance with standards such as ISO 9001, ISO 13485, and ISO 14001.
Responsibilities include preparing certification documentation, coordinating audit schedules, and assisting departments in maintaining quality management systems aligned with ISO standards. Regulatory Specialist Job SI Surgical
CE Marking and European Compliance
The Regulatory Specialist will assist in ensuring that products meet the requirements for CE marking. This includes preparing technical documentation, coordinating with certification bodies, and maintaining compliance with European safety and regulatory requirements.
The role may also involve preparing submissions and ensuring regulatory documentation meets the necessary standards for product approval in European markets.
BIS Certification Management
Another important responsibility includes managing compliance with Bureau of Indian Standards (BIS) certification requirements.
The candidate will coordinate certification applications, maintain communication with regulatory authorities, and ensure documentation is prepared according to regulatory guidelines.
Internal and External Audit Coordination
The regulatory team conducts routine internal audits to verify compliance with quality standards. The Regulatory Specialist will assist in organizing these audits and ensuring documentation is prepared correctly.
They will also support external audits conducted by certification bodies or regulatory agencies. Identifying compliance gaps and implementing corrective actions will be an important part of this responsibility.
Regulatory Documentation Management
Maintaining proper documentation is a critical aspect of regulatory affairs. The candidate will be responsible for organizing quality manuals, procedures, certifications, and other regulatory records.
Ensuring that documentation remains updated according to changing regulatory requirements is essential for maintaining compliance.
Cross-Functional Collaboration
Regulatory professionals work closely with multiple departments including product development, manufacturing, and quality control.
The Regulatory Specialist will coordinate with these teams to ensure that compliance standards are maintained throughout the product lifecycle.
Training and Compliance Awareness
The role may also involve conducting internal training sessions to improve regulatory awareness among employees. These sessions help ensure that teams remain prepared for certification audits and regulatory inspections.
Risk Assessment and Compliance Improvement
Identifying regulatory risks and recommending preventive measures will be an important aspect of the job. The Regulatory Specialist will contribute to continuous improvement initiatives within the organization’s quality and compliance systems. Regulatory Specialist Job SI Surgical
Eligibility Criteria
Candidates interested in applying for this role should meet the following eligibility requirements.
Education
Applicants must possess a Bachelor’s degree in one of the following fields:
- Engineering
- Regulatory Affairs
- Quality Management
- Business Administration
- Any other related discipline
Additional certifications related to ISO standards are considered advantageous.
Experience
- Minimum 3 to 5 years of professional experience in regulatory affairs, certification management, or quality compliance roles.
- Experience working with regulatory certifications such as ISO, CE marking, or BIS is highly preferred.
Skills Required
Candidates should demonstrate strong professional competencies including:
- Understanding of ISO standards such as ISO 9001, ISO 13485, and ISO 14001
- Knowledge of CE marking procedures and regulatory requirements
- Familiarity with BIS certification processes in India
- Experience preparing regulatory documentation and compliance reports
- Ability to coordinate certification audits and regulatory inspections
- Strong communication and documentation skills
- Proficiency in Microsoft Office tools including Excel, Word, and PowerPoint
- Experience using Quality Management Systems (QMS) or regulatory software
Salary & Benefits
The company offers a monthly salary ranging between ₹20,000 and ₹25,000 for the Regulatory Specialist role.
Working in regulatory affairs also provides exposure to international compliance frameworks and industry certification standards. Professionals in this domain often gain valuable expertise in regulatory strategy, documentation management, and audit coordination.
Such experience can support long-term career growth in regulatory affairs, quality management, and healthcare compliance roles. Regulatory Specialist Job SI Surgical
Selection Process
The recruitment process for this position may include the following stages:
- Application Screening – Evaluation of candidate profiles and experience.
- Shortlisting – Candidates meeting the required criteria will be shortlisted.
- Interview Round – Shortlisted applicants may be invited for an interview with the regulatory or HR team.
- Final Selection – Successful candidates will receive confirmation from the company.
The exact selection process may vary depending on the organization’s recruitment policies. Regulatory Specialist Job SI Surgical
How to Apply
Interested candidates who meet the eligibility criteria can apply for the Regulatory Specialist position at SI Surgical Pvt Ltd through the company’s official recruitment channels or online job platforms. Regulatory Specialist Job SI Surgical
Applicants should ensure that their resume clearly highlights:
- Experience with ISO certification processes
- Knowledge of CE marking and regulatory documentation
- Experience in regulatory audits and compliance management
Providing detailed regulatory experience in the resume can improve the chances of being shortlisted.
Important Dates
- Application Start Date: Already Open
- Last Date to Apply: Not Specified by the Company
Candidates are advised to apply as early as possible to increase their chances of selection. Regulatory Specialist Job SI Surgical
Why Apply for This Pharma Job?
The Regulatory Specialist role offers a valuable opportunity to build expertise in regulatory affairs within the medical device industry. Professionals in this field play a crucial role in ensuring product safety, compliance, and regulatory approvals. Regulatory Specialist Job SI Surgical
Working in regulatory compliance provides exposure to international certification frameworks such as ISO and CE marking, which are highly valued in healthcare and manufacturing sectors. Candidates who develop experience in these areas often have strong career prospects in regulatory affairs, quality assurance, and compliance management.
This role is particularly suitable for professionals looking to strengthen their regulatory knowledge while contributing to maintaining high standards in healthcare manufacturing. Regulatory Specialist Job SI Surgical
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent job information platform created to share pharmaceutical and healthcare industry job updates for educational and informational purposes.
We do not conduct recruitment, charge any fees, or represent any company mentioned in the job postings. Applicants are advised to verify all job details directly with the official company sources before applying. Regulatory Specialist Job SI Surgical
Final Call-to-Action
Candidates with relevant experience in regulatory affairs, certification management, and quality compliance should consider applying for this opportunity. Ensure that your application highlights regulatory documentation experience, audit coordination skills, and familiarity with ISO and CE standards to improve your chances of being shortlisted for the Regulatory Specialist role at SI Surgical Pvt Ltd. Regulatory Specialist Job SI Surgical
