BioTalent
Principal Quality & Regulatory Specialist
We are seeking a Principal-level Quality and Regulatory Affairs professional to lead and support global regulatory strategy and quality system compliance for a growing IVD organization. This is an excellent opportunity for a senior professional to contribute significantly to the company's global product growth. Key Responsibilities: Serve as the in-house expert on global IVD regulatory submissions, including FDA 510(k), EU IVDR, Health Canada, APAC, and other international markets. Develop, execute, and manage regulatory strategies to ensure successful product registrations and compliance across global markets. Provide strategic guidance on regulatory requirements throughout the product lifecycle. Oversee and strengthen the Quality Management System (QMS) in compliance with ISO 13485, 21 CFR Part 820, and applicable international standards. Partner cross-functionally to support audits, inspections, and continuous improvement initiatives. Mentor junior staff and advise leadership on regulatory risk and quality best practices. Qualifications: Proven experience in regulatory affairs and quality within the IVD or medical device industry. Successful track record with global submissions, including FDA, EU IVDR, and other international regulatory bodies. Deep knowledge of quality systems and standards (ISO 13485, QSR, etc.). Excellent communication and leadership skills. Advanced degree or RAC certification is a plus. Seniority level
Associate Employment type
Full-time Job function
Quality Assurance Industry
Medical Equipment Manufacturing This job is currently active and accepting applications.
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We are seeking a Principal-level Quality and Regulatory Affairs professional to lead and support global regulatory strategy and quality system compliance for a growing IVD organization. This is an excellent opportunity for a senior professional to contribute significantly to the company's global product growth. Key Responsibilities: Serve as the in-house expert on global IVD regulatory submissions, including FDA 510(k), EU IVDR, Health Canada, APAC, and other international markets. Develop, execute, and manage regulatory strategies to ensure successful product registrations and compliance across global markets. Provide strategic guidance on regulatory requirements throughout the product lifecycle. Oversee and strengthen the Quality Management System (QMS) in compliance with ISO 13485, 21 CFR Part 820, and applicable international standards. Partner cross-functionally to support audits, inspections, and continuous improvement initiatives. Mentor junior staff and advise leadership on regulatory risk and quality best practices. Qualifications: Proven experience in regulatory affairs and quality within the IVD or medical device industry. Successful track record with global submissions, including FDA, EU IVDR, and other international regulatory bodies. Deep knowledge of quality systems and standards (ISO 13485, QSR, etc.). Excellent communication and leadership skills. Advanced degree or RAC certification is a plus. Seniority level
Associate Employment type
Full-time Job function
Quality Assurance Industry
Medical Equipment Manufacturing This job is currently active and accepting applications.
#J-18808-Ljbffr