Compliance Manager ( Surgical Industry Experience)

The Compliance Manager role based in Sialkot, Pakistan, offers an excellent opportunity for a professional with 3 to 5 years of experience in compliance, quality assurance, or regulatory affairs within the surgical instruments or medical device manufacturing sector. The successful candidate will be responsible for ensuring adherence to international standards and regulatory requirements, including ISO certifications and EU Medical Device Regulation (MDR). This position requires strong expertise in Quality Management Systems (QMS), social compliance audits, and regulatory documentation, with a focus on maintaining and improving compliance across multiple departments.

Key Responsibilities

- Ensure company-wide compliance with ISO 9001, ISO 13485, ISO 14001, ISO 45001, EU MDR 2017/745, and SEDEX/SMETA standards.
- Independently prepare, review, update, and maintain QMS documentation, including Quality Manuals, Standard Operating Procedures (SOPs), Work Instructions, and medical device Technical Files.
- Conduct internal audits to identify compliance gaps and implement corrective and preventive actions (CAPA).
- Manage SEDEX/SMETA audit preparation, including social compliance documentation and follow-up on corrective actions.
- Coordinate external certification audits, customer inspections, and regulatory assessments to ensure ongoing conformity.
- Develop and maintain policies related to labor compliance, employee welfare, workplace health and safety, environmental practices, and business ethics.
- Monitor changes in applicable regulations and ensure timely updates to company systems and procedures.
- Collaborate with Quality Assurance, Production, Human Resources, and Management teams to maintain compliance across all departments.
- Maintain detailed audit reports, risk assessments, CAPA records, and regulatory documentation.

Required Qualifications

- Bachelor’s or Master’s degree in Engineering, Quality Management, Regulatory Affairs, or a related discipline.
- 3 to 5 years of practical experience in compliance, quality assurance, or regulatory affairs, preferably within the surgical instruments or medical device manufacturing industry.
- Strong knowledge and hands-on experience with ISO 9001, ISO 13485, ISO 14001, ISO 45001, EU MDR 2017/745, and SEDEX/SMETA requirements.
- Expertise in preparing, implementing, and maintaining Quality Management System documentation, including Quality Manuals, SOPs, Work Instructions, Forms, and Records.
- Proven experience in managing EU MDR Technical Documentation, Technical Files, Risk Management Files, General Safety and Performance Requirements (GSPR) Checklists, and Declarations of Conformity.
- Experience in SEDEX/SMETA social compliance audits covering labor standards, occupational health and safety, business ethics, and environmental compliance.
- Ability to independently manage ISO certification processes, EU MDR conformity assessments, customer audits, and SMETA audit preparations.
- Strong skills in conducting internal audits, root cause analysis, CAPA, risk management, and regulatory compliance.
- Experience in developing compliance policies, employee training programs, and corrective action plans.
- Excellent documentation, reporting, communication, and organizational skills.
- Proficiency in Microsoft Word, Excel, and compliance record management systems.

Preferred Qualifications and Benefits

- Practical experience in independently preparing Quality Manuals, SOPs, Technical Files, and audit documentation is essential.
- The role requires working on-site in Sialkot, ensuring hands-on management of compliance activities.
- The monthly salary range for this position is Rs 50,000 to Rs 100,000, reflecting experience and qualifications.

This position is ideal for a detail-oriented professional who thrives in a regulatory environment and is committed to maintaining the highest standards of quality and compliance in the medical device industry.