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Cytonome has an immediate opening for an experienced, full-time Director of Quality & Regulatory!

This position is in office in Lexington, MA and does not offer relocation assistance.

The Director of Quality & Regulatory will possess strong Quality, Regulatory & Safety knowledge, analytical skills, excellent communication skills, a collaborative style, the ability to influence Quality, Regulatory & Safety within and outside the organization and a have a strong customer focus.

• Drive Quality, Regulatory & Safety strategies for the company
• Build and manage the QARA team
• Responsible for driving Quality, Regulatory & Safety compliance initiatives in a fiscally
• responsible manor to meet business needs.

Cytonome was founded in 2009 on the premise of providing advanced solutions for cell purification needs. By developing cutting-edge technologies in cell purification and platform design, Cytonome provides novel solutions for cell therapy, research and industry. With deep engineering expertise in the cytometry field and an expansive intellectual property portfolio, Cytonome aims to develop products that simplify existing workflows and enable leading-edge advances and research.

Job Responsibilities:

• Be the leader of the Quality, Regulatory & Safety function by designing and implementing appropriate Quality, Regulatory & Safety systems and programs.
• Advise the organization on applicable Quality, Regulatory & Safety requirements and standards.
• Manage the QARA function, ensuring the QARA team activities are planned, resources allocated, priorities established and activities executed.
• Ensure the business remains compliant with local, federal and global Quality, Regulatory & Safety regulations and standards.
• Implement, oversee and maintain NCMR, CAPA (Corrective and Preventative Actions), complaints, validations, s/w validations, inspections, document control, supplier quality and problem resolution processes.
• Conduct Quality and Safety Audits and assure timely corrective actions.
• Manage external Auditors and Regulatory Agencies on-site audits and follow-ups.
• Is the Quality Management Representative, fulfilling the requirements of ISO.
• Working cross functionally to assure design & change control systems are effective.
• Establish, maintain and assure product safety and regulatory filings and compliance enabling timely US and global product registrations and licensing.
• Review & approve product labeling & marketing literature for regulatory compliance.
• Manage product vigilance reporting and responses to Regulatory Agencies.
• Promote quality/regulatory/safety awareness throughout the organization.
• Educate/train company employees on quality/regulatory/safety matters to assure compliance with requirements.
• Managerial responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
• Adhere to applicable laws, regulations and Company’s policies, procedures, including quality management (ISO-9001, ISO-13485, FDA QSR, GMP, etc.), environmental, safety and health (OSHA, EPA, DOT, MWRA, etc.);

MINIMUM REQUIREMENTS & EXPERIENCE NECESSARY TO PERFORM POSITION EFFECTIVELY: Educational Background:

• Bachelor’s Degree in Engineering or Scientific discipline, Master’s degree preferred

Required experience:

• 10 years of broad experience in Quality Assurance, Regulatory Affairs, Compliance and Safety
• 10 years’ experience in progressive leadership and management

Other Requirements:

• Experience in medical device or pharmaceutical industry
• Experience in research & development, preferably medical device or biolab
• Excellent interpersonal and communication skills and sound organizational skills
• Must be able to multi-task and evaluate priorities

Cytonome excels in creating a workplace where imaginative thinkers can participate in a stimulating entrepreneurial environment and contribute to a highly motivated, success-driven team. Cytonome is an equal opportunity employer. The stated policy of the Company prohibits unlawful discrimination on the basis of race, sex, sexual orientation, religion, color, national origin, age, disability, citizenship, pregnancy, veteran status, or other characteristics protected by federal, state, and/or local law.