Regulatory Affairs Manager
On-siteEden Prairie, Minnesota, United States
Job Summary
Lead regulatory functions as the company's Management Representative and Person Responsible for Regulatory Compliance (PRRC). Recruit, interview, and hire new employees while overseeing daily department workflow and providing constructive performance evaluations. Manage Regulatory Strategy, Product Registration, Device History Record Reviews, and Design History File Maintenance. Serve as the Notified Body liaison for CE marked products and act as the lead contact for regulatory agency inspections. Coordinate regulatory submissions to FDA and international agencies, review product changes via Engineering Change Orders, and oversee post-market activities including vigilance reporting. Create quality system procedures and ensure adherence to 21 CFR Part 820, ISO 13485, EU MDR, and Canadian regulations. This role requires up to 15% domestic and international travel and involves frequent interruptions to adjust priorities quickly.
Required Qualifications
- Bachelor's Degree
- Minimum of 10 years progressively responsible experience in the medical device industry
- Minimum of 7 years within quality systems and/or regulatory compliance functions
- Experience with Regulatory requirements for medical devices
- 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
- European requirements/regulations
- Travel up to 15% of the time
- Must be able to lift up to 25 pounds
Desired 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
- Service-oriented approach, flexible and proactive towards changing needs
- Exceptionally team focused and actively contribute to a positive and innovative work environment
- Work precisely according to procedures, rules, and regulations, and have a passion for continuous improvement and quality
- 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
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