Regulatory Manager at PaxeraHealth

, , -

Full Time

Start Date

Immediate

Expiry Date

04 May, 26

Salary

0.0

Posted On

03 Feb, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Compliance Management, Quality Assurance, Risk Management, Leadership, Regulatory Affairs, ISO Standards, Internal Audits, Continuous Improvement, Documentation, Training, Communication, Organizational Skills, Problem Solving, Team Collaboration, Regulatory Compliance, Process Optimization

Industry

Hospitals and Health Care

Description

Job Description: 1. Compliance Management Oversee all aspects of compliance with regulatory requirements, industry standards, and internal policies. Lead efforts to obtain and maintain certifications (e.g., ISO 9001,ISO 27000, ISO 13485, FDA , MDR, and other relevant quality/compliance standards). Ensure ongoing adherence to all applicable regulations, proactively identifying and addressing areas for improvement. Review, update, and maintain all regulatory files and documentation, ensuring timely submissions and filings. Monitor and interpret changes in laws, regulations, and industry standards; advise management on compliance implications. 2. Quality Assurance Implement and manage the company’s Quality Management Systems (QMS). Collaborate with operations, product, and other teams to ensure products, services, and processes meet compliance and quality benchmarks. Conduct regular internal audits and assessments to evaluate compliance and certification readiness. Drive continuous improvement in quality processes through monitoring, feedback, and corrective action. 3. Risk Management & Reporting Develop and implement a risk management strategy to address potential non-compliance or quality issues. Maintain a compliance and certification risk register, ensuring risks are documented and mitigated. Monitor and report on the company’s compliance status, providing regular updates to senior leadership. Investigate and resolve compliance-related issues or incidents, ensuring thorough root-cause analysis and preventive measures. 4. Collaboration & Leadership Partner with operations, product, and cross-functional teams to embed compliance into daily workflows. Act as the primary liaison for regulatory bodies, certification auditors, and external inspections. Provide training, awareness programs, and guidance to employees on compliance standards, policies, and regulatory requirements. Foster a culture of integrity, accountability, and continuous learning across the organization. 5. Process Improvement Lead continuous improvement initiatives to streamline compliance and certification processes. Enhance efficiency by automating and simplifying compliance workflows where possible. Stay updated on new regulations, compliance frameworks, and industry trends to anticipate and prepare for potential business impacts. Benchmark internal processes against best practices and recommend process optimizations. Qualifications and Skills: Bachelor’s degree in compliance, regulatory affairs, business administration, or related field. At least 3-5 years of experience in compliance, regulatory management, or quality assurance, ideally within the healthcare or software industry. Strong knowledge of industry regulations, quality standards (ISO), and compliance processes. Experience with obtaining ISO 9001,ISO 27000, ISO 13485, FDA , MDR. Excellent English Language. Excellent organizational, leadership, and communication skills. Ability to manage multiple projects and deadlines in a fast-paced environment.

Responsibilities

The Regulatory Manager will oversee compliance with regulatory requirements and lead efforts to maintain certifications. They will also implement and manage the Quality Management Systems and collaborate with cross-functional teams to ensure adherence to quality benchmarks.