Senior Manager - Certifications

Job Description: Senior Manager Certifications (Nitrile Gloves Export Sales)

Position: Senior Manager Certifications

Department: Export Sales

Location:Kolkata / Kharagpur

Reports To:Business Head - Export

Job Summary:

The Senior Manager Certifications will be responsible for managing and obtaining necessary regulatory certifications and compliance approvals for nitrile gloves in various international markets. This role ensures that all exported products meet the required industry standards, regulatory guidelines, and customer specifications. The position also involves coordinating with internal teams and external regulatory bodies to streamline certification processes and support business growth.

Key Responsibilities:

1. Certification & Regulatory Compliance:

• Lead and manage the certification process for nitrile gloves in export markets (e.g., FDA (USA), CE (Europe), ISO, ASTM, EN standards, TGA (Australia), and other country-specific regulations).
• Ensure all product registrations, audits, and approvals are completed in a timely manner.
• Stay updated on global regulatory changes affecting nitrile gloves and advise internal stakeholders.
• Work closely with third-party testing agencies, auditors, and regulatory consultants to ensure compliance.

2. Documentation & Process Management:

• Prepare, review, and maintain all necessary documentation required for certifications, including technical dossiers, MSDS, test reports, and quality certifications.
• Collaborate with the quality assurance (QA), R&D, and production teams to ensure compliance with international standards.
• Implement and improve SOPs for regulatory approvals and compliance management.

3. Liaison with External & Internal Stakeholders:

• Act as a key point of contact for regulatory authorities and certification bodies.
• Support the sales and export teams by providing necessary compliance documents for international shipments.
• Conduct internal training sessions to educate the sales and operations teams on export certification requirements.

4. Market Expansion & Strategic Compliance Planning:

• Identify new regulatory requirements in potential export markets to expand business opportunities.
• Develop a strategic roadmap for securing certifications in new markets.
• Provide regulatory guidance on product modifications or new product development to ensure compliance.

5. Audit & Inspection Readiness:

• Ensure that manufacturing and quality processes comply with GMP, ISO 13485, and other relevant quality management systems.
• Prepare for and manage regulatory inspections, customer audits, and certification renewals.
• Implement corrective actions based on audit findings to maintain continuous compliance.

Key Qualifications & Experience:

• Education: Bachelor’s or Master’s degree in Pharmaceuticals, Life Sciences, Regulatory Affairs, Chemistry, or related fields.
• Experience: Minimum 8-12 years of experience in certifications, regulatory compliance, or quality assurance, preferably in nitrile gloves, medical devices, or PPE exports.
• Certifications: Knowledge of FDA, CE, ISO 13485, ASTM, EN 455/374, MDR, and other international regulatory frameworks is essential.
• Technical Skills: Strong understanding of regulatory documentation, product testing requirements, and quality management systems.
• Soft Skills: Excellent communication, negotiation, project management, and problem-solving skills.
• Languages: Proficiency in English; additional language skills (e.g., French, Spanish, or Mandarin) are a plus for global market interactions.

Why Join Us?

• Opportunity to work with a leading nitrile glove exporter and expand regulatory expertise in global markets.
• Collaborate with international teams and build a strong network in the export compliance sector.
• Competitive salary and benefits package with growth opportunities in the regulatory domain.

If you have the experience and passion for ensuring compliance in nitrile glove exports, we invite you to be a part of our dynamic team!

To Apply: Please send your CV to srmanagerhr@rashmigroup.com with the subject line Application for Senior Manager – Certifications.