Regulatory Affairs Manager at HearingLife in Eden Prairie, MN

Overview

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.

Responsibilities

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.

Qualifications

• 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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