The Regulatory Affairs Manager is responsible for leading regulatory functions and serves as management representative. Responsibilities include ensuring compliance with medical device standards and regulations, which include: 21 CFR Part 820 Quality system Regulation (QSR), ISO 13485, Regulation (EU) 2017/745 (MDR), and SOR/98-282 Canadian Medical Device Regulations (CMDR). In addition, they will support Manufacturing and Engineering functions in all phases of design, development, production, and distribution of medical devices.

Supervisory Responsibilities:

• Recruit, interview, and hire new employees.
• Provide training to employees where necessary.
• Oversee the daily workflow of the department.
• Oversee, supervise, and provide direction in the following areas: Regulatory Strategy, Product Registration and Market Clearance, Device History Record Review, Employee Training, Design History File Maintenance, and Labeling.
• Serve as Notified Body liaison, maintaining technical files of CE marked products and filing amendments to product files, as required.
• Provide constructive and timely performance evaluations. 
• Handle discipline and termination of employees in accordance with company policy.
• Perform other related duties as assigned.

Duties/Responsibilities:

• Serve as company Management Representative, to ensure that quality management system requirements are effectively established and maintained in accordance with medical device regulations and international standards.
• Serve as Person Responsible for Regulatory Compliance (PRRC) according to Article 15 of EU MDR 2017/745.
• Serve as lead contact for inspections by regulatory agencies.
• Coordinate preparation activities and ensure the company maintains a state of readiness for inspections.
• Represent the Regulatory function on project teams, providing regulatory compliance input, feedback, and guidance.
• Review and approve product and manufacturing changes via Engineering Change Order (ECO) approval to ensure adherence to regulatory requirements.
• Assess the impact of changes on current clinical investigations and FDA filings.
• Review device labeling and advertising materials for compliance with US and international labeling regulations.
• Create and revise quality system procedures, as required.
• Oversee the implementation of applicable post market activities. Post market studies are conducted in conjunction with Clinical department and Marketing.
• File Vigilance reports and MDRs when required.
• Coordinate regulatory submissions made to FDA and other regulatory agencies (domestic and international) to obtain clinical and product approvals and respond to inquiries.
• Perform a variety of duties with frequent interruptions or distractions, adjusting priorities quickly as circumstances dictate.
• All other duties as assigned.

• Ability to identify areas for improvement and implement solutions, ensure compliance to standards, regulations, and company procedures, and administer successful programs within a timeline.
• Ability to interact positively with all levels of staff and external contacts.
• Excellent writing, composition, and English grammar skills.
• Ability to maintain and communicate realistic schedules and meet strict deadlines.
• Must have a service-oriented approach, flexible and proactive towards changing needs.
• Must be exceptionally team focused and actively contribute to a positive and innovative work environment.
• Must work precisely according to procedures, rules, and regulations, and have a passion for continuous improvement and quality.
• Ability to demonstrate the highest ethical standards, and actively promote trust, respect and integrity in all dealings both inside and outside the Company.
• Excellent verbal and written communication skills.
• Excellent organizational skills and attention to detail.
• Strong analytical and problem-solving skills.
• Strong supervisory and leadership skills.
• Ability to prioritize tasks and to delegate them when appropriate.
• Ability to function well in a high-paced and at times stressful environment.
• High level of proficiency in Microsoft Word, Outlook, Excel, and PowerPoint.

Education and Experience:

• Bachelor's Degree or equivalent is required; Minimum of 10 years progressively responsible experience in the medical device industry is required; Minimum of 7 years within quality systems and/or regulatory compliance functions is required.
• Experience with Regulatory requirements for medical devices are necessary, including: 21 CFR Part 820 Quality System Regulation (QSR), EN ISO 13485, Medical Devices-Quality management systems.
• Minimum of four years of professional experience in regulatory or quality management systems for medical devices, with specific regard to European requirements/regulations.

Travel:

• This position is subject up to travel up to 15% of the time to include both domestic and international travel.

Physical Requirements:

• Prolonged periods of sitting at a desk and working on a computer.
• Must be able to lift up to 25 pounds at times. 

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