Primo Medical Group is an industry leader in the development, manufacture and assembly of quality medical devices and precision machined components, currently with four locations.
We are looking for a hands-on Quality & Regulatory Manager to join a medical device company based south of Boston. Our innovative company offers a competitive salary, excellent benefits and opportunity for professional advancement.

EDUCATION/EXPERIENCE:

• Relevant Bachelor’s Degree required; Masters preferred.
• 5-7 plus years related experience in medical device industry, at least 3 years direct responsibility for implementation and upholding of complete medical device quality and regulatory management systems.
• Thorough understanding of FDA Quality System Regulations 21 CFR 820 and ISO 13485 standards & requirements.
• Excellent writing skills with ability to prepare FDA filings and write technical reports.
• Strong interpersonal skills are needed to interact with all levels of the company.
  Job Type: Full-time
  Pay: $140,000.00 - $160,000.00 per year

Benefits:

• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Ability to Commute:

• West Bridgewater, MA 02379 (Required)

Work Location: In perso

Reporting directly to the Chief Operating Officer, the Quality & Regulatory Manager will manage the quality management system and regulatory requirements for the company.

• Responsible for maintaining Quality Management System according to FDA QSR and ISO 13485 regulations. Leads audits relative to such regulations and implements continuous improvement initiatives to maintain a robust Quality Management System.
• Manage FDA regulatory filings, including the maintenance of existing products and new product launches. Work closely with Principal Engineers to determine regulatory pathways and prepare FDA submissions.
• Partner with product development teams to ensure Design Control Procedures are followed.
• Work with Customer Service, Sales Personnel and necessary departments to document, investigate and close Customer Complaints.
• Responsible for proper execution of company Corrective and Preventive Action process for CAPAs stemming from audits, customer complaints or other sources.
• Record and trend Quality Management System activities for presentation to the management team including CAPA, Nonconformance, Complaint, and audits, etc.
• Present information at Management Review.
• Maintains up to date Quality Management System procedures and ensures completion of documented training. Implement procedure changes to quality system documents using the DCR system.
• Identifies Critical Suppliers. Maintains Approved Supplier Files including supplier qualification & continued evaluation. Performs supplier audits as required

Reporting directly to the Chief Operating Officer, the Quality & Regulatory Manager will manage the quality management system and regulatory requirements for the company.

• Responsible for maintaining Quality Management System according to FDA QSR and ISO 13485 regulations. Leads audits relative to such regulations and implements continuous improvement initiatives to maintain a robust Quality Management System.
• Manage FDA regulatory filings, including the maintenance of existing products and new product launches. Work closely with Principal Engineers to determine regulatory pathways and prepare FDA submissions.
• Partner with product development teams to ensure Design Control Procedures are followed.
• Work with Customer Service, Sales Personnel and necessary departments to document, investigate and close Customer Complaints.
• Responsible for proper execution of company Corrective and Preventive Action process for CAPAs stemming from audits, customer complaints or other sources.
• Record and trend Quality Management System activities for presentation to the management team including CAPA, Nonconformance, Complaint, and audits, etc.
• Present information at Management Review.
• Maintains up to date Quality Management System procedures and ensures completion of documented training. Implement procedure changes to quality system documents using the DCR system.
• Identifies Critical Suppliers. Maintains Approved Supplier Files including supplier qualification & continued evaluation. Performs supplier audits as required.