JOIN OUR TEAM!
As an innovator of the next generation of neurointerventional medical devices, MIVI Neuroscience employees are passionate about making a difference in patients’ lives and we are looking for like-minded individuals to join our team. If you are a highly motivated and self-driven individual looking to use your experience and talent to make a real impact in the fast-growing neurovascular stroke market, we would love to talk with you!
|Job Title: Senior Manager Regulatory Affairs
|Location: Eden Prairie / Remote|
|Department: Regulatory Affairs|
|Reports to: Heather Cronin|
|Title: VP Reg/Clin|
|Ideal candidates would be based local to Minneapolis, MN although remote candidates may be considered for this role.|
|Type of position:||Hours 40 week|
|X Full-time||X Exempt|
This position will be responsible for MIVI Neuroscience’s regulatory submissions to ensure company products are in accordance with regulatory bodies worldwide and government compliance. Primary areas of responsibility include driving domestic US FDA submissions, including pre-market notifications 510(k), investigational device exemptions (IDE), and pre-market approval (PMA) applications. This role also requires leadership in preparation of international regulatory pre-market submissions for class III design dossiers, class I/IIa/IIb technical files worldwide including bringing products to EU MDR compliance. The Senior Manager of Regulatory Affairs must identify regulatory requirements, assess and communicate such requirements, submission strategies and risks to the organization. The position will interface with relevant regulatory authorities and notified bodies to support company regulatory/compliance goals.
- Develop and execute long range regulatory strategies in the United States and Internationally
- Provides guidance and technical expertise to assure that all necessary domestic and international regulatory activities are in governmental compliance
- Experience with regulatory assessments for change orders
- Manage Regulatory Affairs activities and team members, represent Regulatory Affairs at project team meetings
- Responsible for regulatory submissions to the FDA and other International Regulatory Authorities, maintaining Design Dossiers and Technical Files for CE Marked product
- Ensure compliance with current domestic, international, and company regulatory compliance requirements (Including but not limited to FDA, PMA, IDE, 510(k) Notifications, and EU requirements)
- Support FDA submissions and Annual Reports, audits
- Ensure incidents, complaints, and Adverse Events are identified, documented, and reported to FDA and other agencies within appropriate timeframes
- Monitor changes in domestic and international regulations and implement within MIVI Neuroscience’s procedures
- Depending on location, travel may be required (up to 10%)
Work Experience Requirements
- Extensive knowledge of global medical device regulations, guidance, and standards, such as, but not limited to FDA, ISO, EU MDR
- Effective in completing product registration in the US and EMEA
- Demonstrated leadership and contribution; a team player and able to work in a team environment while delivering as an individual contributor
- Self-motivated and independent
- Understand the resources, time and expertise required to complete projects and deliverables in a timely manner
- Effective interpersonal skills/diplomacy and problem-solving techniques
- Proficient computer skills; able to use standardized office software products, ie., Microsoft Word, Excel, PowerPoint
- International Regulatory experience
- Experience with MDD to EU MDR conversion and EU MDR requirements regarding post-market vigilance
- Experience with GDPR requirements and implementation within SOPs
- 8+ years of regulatory affairs experience in a medical device manufacturing environment
- Experience obtaining 510K and CE mark on products
- Experience with Neurovascular products
- Bachelor’s degree required, preference degree is in a technical field (Science, Engineering, Technology)
- Preferred graduate degree
MIVI is always looking for talented and creative people.
Please feel free to send an email to: firstname.lastname@example.org
MIVI Neuroscience is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.