SI Surgical Pvt Ltd is hiring a Regulatory Specialist to manage regulatory certifications and compliance activities related to ISO standards, CE marking, and BIS certification. This role is ideal for professionals experienced in regulatory affairs and quality management systems who can ensure the organization meets both national and international compliance requirements.
The selected candidate will work closely with cross-functional teams to maintain certifications, coordinate audits, and ensure proper regulatory documentation for products and processes.
Author: Pharmabharat Editorial Team
Job Overview
Company: SI Surgical Pvt Ltd
Position: Regulatory Specialist
Location: Howrah, West Bengal, India
Salary: ₹20,000 – ₹25,000 per month
Experience: 3–5 Years
Industry: Medical Devices / Manufacturing / Healthcare Compliance
This role plays an important part in maintaining regulatory compliance across multiple standards and ensuring smooth certification processes for products and systems.
Key Roles and Responsibilities
ISO Certification Management
- Coordinate the ISO certification process such as ISO 9001, ISO 13485, and ISO 14001.
- Monitor compliance with ISO standards and maintain documented procedures.
- Prepare required documentation for certification audits and renewals.
- Support departments to maintain continuous improvement within quality systems.
CE Marking Compliance
- Assist in obtaining and maintaining CE certification for products.
- Ensure products meet European safety, health, and environmental requirements.
- Prepare technical documentation and regulatory submissions.
- Coordinate with notified bodies for CE marking approvals.
BIS Certification Management
- Facilitate Bureau of Indian Standards (BIS) certification for relevant products.
- Handle communication with BIS for documentation and certification applications.
- Stay updated with changes in BIS regulations and compliance guidelines.
Audit Management
- Conduct internal audits to verify compliance with ISO, CE, and BIS standards.
- Coordinate external audits from certification bodies and regulatory authorities.
- Identify compliance gaps and implement Corrective and Preventive Actions (CAPA).
- Prepare audit reports and monitor improvement actions.
Regulatory Documentation
- Maintain regulatory documentation including quality manuals, procedures, and certifications.
- Ensure documentation remains updated according to regulatory changes.
- Track regulatory updates impacting certification and product compliance.
Training and Cross-Functional Support
- Conduct internal training sessions on regulatory compliance and audit readiness.
- Collaborate with product development, quality control, and manufacturing teams.
- Support departments to ensure compliance throughout product lifecycle stages.
Risk Management and Process Improvement
- Identify regulatory risks and propose mitigation strategies.
- Encourage continuous improvement in compliance processes and quality standards.
- Support organizational efforts to maintain strong regulatory systems.
Required Qualifications
Candidates applying for this role should meet the following criteria:
- Bachelor’s degree in Engineering, Quality Management, Regulatory Affairs, Business, or related field
- Certifications such as ISO Lead Auditor, ISO 9001 or ISO 13485 are preferred
- Strong knowledge of regulatory standards and quality management systems
Required Skills and Knowledge
- Strong understanding of ISO 9001, ISO 13485, ISO 14001
- Knowledge of CE marking processes and EU directives
- Familiarity with BIS certification requirements
- Experience with regulatory documentation and compliance reporting
- Proficiency in Microsoft Office tools (Excel, Word, PowerPoint)
- Experience using Quality Management Systems (QMS) or regulatory software
Preferred Experience
- 3 to 5 years of experience in regulatory affairs or certification management
- Experience handling ISO, CE, and BIS certification audits
- Exposure to industries such as manufacturing, healthcare, electronics, or pharmaceuticals
Salary and Benefits
- Salary range: ₹20,000 – ₹25,000 per month
- Opportunity to work in regulatory and quality compliance roles
- Experience in international regulatory frameworks
- Career growth in regulatory affairs and quality management
Work Environment
Regulatory Specialists generally work in office environments but may occasionally travel for:
- Regulatory audits
- Certification inspections
- Meetings with regulatory bodies or certification agencies
Industries employing professionals in this role include medical devices, manufacturing, electronics, healthcare, and pharmaceuticals.
How to Apply
Interested candidates who meet the qualification and experience requirements can apply for the Regulatory Specialist position at SI Surgical Pvt Ltd through the company’s recruitment channels or professional job platforms.
Ensure your resume highlights experience in ISO certifications, regulatory documentation, and audit coordination to improve your chances of selection.