Senior Compliance Manager (Healthcare Industry) - Remote

Overview

An experienced Senior Compliance Manager is needed to enhance expertise in the healthcare domain and help expand business in this area.

In Short

• Stay informed on healthcare regulations (MDR/IVDR, FDA, GMP).
• Identify solutions for clients to achieve faster market entry.
• Analyze client needs and develop proposals.
• Conduct gap analysis to assess compliance.
• Communicate with potential partners and clients.
• Stay updated on regulatory changes.
• Create job descriptions and conduct interviews for consultants.
• Assist in project phases by creating work plans.

Requirements

• In-depth understanding of healthcare regulations.
• Experience in maintaining QMS compliant with ISO standards.
• Experience in preparing technical documentation for certification.
• Familiarity with computer system validation principles.
• Strong background in conducting audits under relevant requirements.
• Ability to communicate complex regulatory requirements effectively.
• Experience in obtaining CE marking for medical devices is a plus.

Benefits

• Opportunity to work in a growing healthcare compliance sector.
• Engagement in meaningful projects that impact healthcare.
• Collaboration with industry experts and partners.