Supervisor, Regulatory Affairs

DENTALEZ • Manheim Township, PA

42d • Onsite

About The Position

The Regulatory Affairs Supervisor assures the company and its products are compliant with all regulatory requirements as directed by the FDA, Health Canada, ISO 13485, and any other applicable organizations or standards.

Requirements

• Associates' degree from two-year college or technical school or equivalent combination of education and experience.
• 2-3 years Regulatory Affairs experience and/or training.
• FDAQMSR requirements.
• Health Canada regulations
• ISO 13485 requirements.
• Working knowledge of Microsoft Office Suite Applications.

Nice To Haves

• RAPS Certifications preferred.
• Internal Auditor Training Certification and/or experience.
• Experience with Oracle, SAP or similar inventory control system a plus.

Responsibilities

• Ensure compliance with FDA Quality Management System Regulations for medical devices and Canadian Medical Device Regulations.
• Oversee the implementation and administration of the quality management system in accordance with ISO 13485.
• Act as the manufacturers primary contact with the FDA and Health Canada and third-party auditors.
• Advise management on issues concerning government regulations and international standards as they pertain to the medical device industry.
• Responsible for completing and filing documentation needed to bring new products to market, including 510(k) and Canadian Licensing. As well as ensuring to update product registrations and licensing as needed, including annual FDA registration, letters to file and Canadian License amendments.
• Compile, analyze and report to management on a monthly and quarterly basis the status of the quality management system and KPI's. Alert management of any undesirable trends.
• Leads and actively participate in all third-party audits. Responsible for the coordination of the corrective actions from the audits and communicating the results of the corrective actions to the appropriate auditing body.
• Manage internal audit program, including training auditors, scheduling audits, preparing audit material, reviewing audit results and monitoring the corrective actions.
• Facilitate internal customer complaint handling system.
• Responsible for sign-off of engineering change orders, rework authorizations, temporary deviations and CAPAs to ensure regulatory and internal procedure compliance.
• Responsible for and managing internal activities regarding product recalls and market withdrawals.
• Participate on interdepartmental teams to ensure regulatory compliance.
• Work with outside environmental consulting agency concerning annual reporting, which includes submitting required annual reports to the appropriate government agency, preparing and submitting quarterly environmental reports, and maintaining all environmental documentation and reporting records.

Benefits

• Competitive Wages
• Work/Life Balance
• Full benefit package including 11 paid holidays, 15 days of paid time off, a company 401(k) match, and insurance
• Clean, safe, and climate controlled work environment
• Stable work in an essential business
• Small interpersonal culture
• Great benefits, including medical, dental, and vision insurance

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree
• Number of Employees: 101-250 employees