Medical Device Quality and Compliance Expert

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🕒 March 17

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Pharmavise Corporation

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2013

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Pharmavise Corporation is the first Continuous Compliance Organization (CCO) dedicated to maintaining the highest standards of quality and regulatory compliance in the life sciences industry. Our esteemed client base includes Fortune 500 companies in pharmaceuticals, medical devices, and biotechnology. We offer bespoke solutions tailored to meet the specific compliance needs of our clients, supporting them from development through commercialization and ensuring they exceed their compliance goals while enhancing patient health and safety.

📋 Description

• Lead and oversee quality management system (QMS) activities for medical device products throughout the product lifecycle. • Develop and implement quality and compliance strategies to ensure adherence to regulatory requirements, standards, and guidelines (e.g., ISO 13485, FDA QSR, MDR). • Conduct risk assessments and mitigation activities to identify and address potential quality and compliance issues. • Provide guidance and support on regulatory submissions and interactions with regulatory agencies (e.g., FDA, notified bodies). • Lead and support internal and external audits, including supplier audits and regulatory inspections. • Collaborate cross-functionally with R&D, manufacturing, regulatory affairs, and other teams to ensure quality and compliance objectives are met. • Stay abreast of emerging regulatory trends and changes affecting the medical device industry and proactively implement necessary updates to QMS processes and procedures.

🎯 Requirements

• Bachelor's degree in engineering, life sciences, or related field; advanced degree preferred. • Minimum of 8 years of experience in quality assurance and regulatory compliance within the medical device industry. • In-depth knowledge of relevant quality standards and regulations, including ISO 13485, FDA QSR, and EU MDR. • Experience leading quality management system implementations and maintaining compliance in a regulated environment. • Strong understanding of risk management principles and methodologies (e.g., ISO 14971). • Excellent communication and interpersonal skills, with the ability to effectively communicate complex regulatory requirements and concepts. • Proven ability to lead and influence cross-functional teams and drive quality and compliance initiatives to completion. • Quality and regulatory certifications (e.g., ASQ CQE, RAC) preferred but not required.

🏖️ Benefits

• Competitive compensation and benefits packages available