Regulatory Affairs Manager
1 month ago
About Our Client:
Our client revolutionizes patient care with cutting-edge hydrogel-based medical devices. Their commitment to self-funding projects, strategic partnerships, and innovative technology positions them as leaders in addressing unmet medical needs.
With over ten spin-off companies and a $4B value, their impact has positively affected over 5 million patients worldwide. Join us in celebrating their commitment to excellence in healthcare solutions
The Role
As the sole Regulatory Affairs Manager, you'll lead the charge in ensuring compliance with regulatory standards for our medical device products. Your role involves strategizing, preparing documentation, and liaising with regulatory agencies to secure marketing approval across different territories. Join us in shaping the future of healthcare compliance and innovation
Key Responsibilities
Formulate and execute regulatory strategies for timely product approvals. Provide regulatory guidance to cross-functional teams to support product development and commercialization.
Regulatory Submissions:
Prepare and submit regulatory documentation for Class III (PMA) and Class II (510(k)) devices.
Liaise with regulatory agencies to facilitate the review process.
Compliance Management:
Monitor and interpret changes to standards and regulations.
Manage ongoing compliance and collaborate with internal teams to address potential gaps.
Risk Management:
Collaborate with cross-functional teams to execute the Risk Management Process and Benefit-Risk Determinations.
Maintain facility registrations in good standing.
Requirements:
Deep understanding of FDA regulations and international medical device standards.
Expertise in quality management systems and regulatory submission processes.
A knack for clear, open communication, fostering collaboration in a fast-paced environment.
Stellar interpersonal skills, enabling seamless collaboration across departments. Ready to dive in and work on-site, making a tangible impact on our exciting projects.
Working Conditions:
Expectation to be in the office in Bedford, MA, core hours between 10-2 4 days per week.
Excellent office environment and very productive space.
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