Senior Regulatory Specialist

PUB384375

About this job

  • Market: Life Sciences & Health Care
  • Industry: Medical devices
  • Area of expertise: Regulatory
  • Location: Burnsville

What is required?

  • Hours per week: 40
  • Education level: Academic Bachelor
  • Closing date: Friday, February 17, 2023

About this role: Senior Regulatory Specialist

The Senior Regulatory Specialist is responsible for planning, managing, and implementing regulatory submissions to the EU notified body, the US FDA, and other country specific regulatory bodies. The position is also responsible for ensuring continued compliance with regulatory agency approvals including change impact reviews.

• Develops domestic and international strategies for regulatory approval of company products.• Coordinates, compiles, and submits U.S. and international regulatory filings for new and modified products, including PMAs, 510(k)s, IDEs, CE Marking submissions, and other country specific product registrations.• Develops and maintains positive relationships with regulatory body reviewers through oral and written communications regarding clarification and follow-up of submissions under review.• Review of product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings.
• Represents RA on cross functional product development, manufacturing, and clinical support teams and provide regulatory leadership and feedback throughout the product development cycle. Provide recommendations for how to overcome regulatory barriers.• Provide technical reviews of supporting documentation for inclusion in regulatory filings.• Support Medical Device Reporting (MDRs) and Medical Device Vigilance Reporting.• Represents RA on other cross functional projects which may include process changes and continuous improvement efforts.
• Meet defined goals and objectives through own initiatives, activities, and available resources with minimal supervision.

What you need to bring:

• Bachelor of Science in a scientific discipline or equivalent education/ training.• 5+ years’ regulatory/compliance related experience in a regulated industry.• Previous experience with US and EU medical device regulatory requirements including Quality Systems and clinical investigations standards.• Australian regulations experience preferred.
• EU MDR transition experience preferred.• Experience with preparation, submission, and approval for medical devices is required.• Strong communication skills, both verbal and written.• Strong analytical and problem-solving skills, as well as a good background in the medical device development process.
• Demonstrated ability to effectively manage multiple projects and priorities.• Skills in multiple computer-based tools and software such as Word, PowerPoint, Excel, and Adobe Acrobat.

Benefits:

Why work with Brunel? We are proud to offer exciting career opportunities from over 100 offices globally in 42 countries. Advancing your career takes time and effort – let us match you to your ideal position.

Anything Else?

Anything Else?

Brunel has a reputation for working with some of the best in the business. That’s what we continually strive for. Over 45 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services.

Start applying immediately

Sending an application is quick and easy. Just make sure you have the required documents ready to go.

  • Job references (optional)
  • Motivation Letter (optional)
  • Resume
Apply now

Any questions remaining?

Your consultant, Meagan Geris is happy to clarify anything about this vacancy. When reaching out, use this number:
PUB384375

Account manager

Meagan Geris
Brunel USA - Minneapolis
m.geris@brunel.net