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Regulatory Affairs Manager

2 months ago

Eden Prairie, United States Demant Full time

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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