Are you inspired by a fast-paced, innovative environment that will challenge you to find creative solutions? At Balt, we foster a culture of collaboration that drives constant innovation. Our goal is to enhance the care of patients with neurovascular disease through physician-inspired innovative solutions. Balt’s 40 year legacy of bringing first-to-market products is now in the US. We are looking for dedicated, creative and collaborative individuals to join us in building the next great neurovascular device company. If this sounds like you, please select from our open positions below.
Director, Regulatory Affairs
Responsible for strategic planning, development, organization and implementation of regulatory requirements to obtain FDA and international regulatory approvals of key medical device products to meet business needs. Shall play an instrumental role in influencing company policies, clinical studies, engineering and manufacturing processes. This position will serve as the regulatory subject matter expert for our business by taking a hands-on role in defining, deploying, and leading regulatory and compliance strategies.
- Prepare / review FDA and international submissions / technical files / product registrations to successfully obtain global commercial distribution of company products.
- Provide guidance, direction and training in regulations, agency guidelines, and internal/corporate policies to ensure compliance and accuracy are achieved.
- Develop regulatory strategies for complex regulatory applications and analyze/ communicate risk vs. benefit to help develop action plans for successful review by regulatory agencies.
- Interpret regulatory rules related to company procedures, clinical studies, engineering testing, and documentation to ensure compliance is maintained.
- Evaluate changes to manufacturing processes and product design against FDA and international requirements and provide guidance to engineering and manufacturing teams.
- Ensure compliance with applicable FDA, GMP, ISO, protocols and regulations.
- Establish metrics for evaluating the quality and timelines of submissions.
- Ensure department compliance with company policies and procedures.
- Manage submission data requirements and deliverable dates and provide regulatory contingency plans for timely submissions to meet business needs.
- Partner with Quality as key contacts for regulatory body interactions including preparation of submissions and strategy for meetings, inspections, and agency responses.
- Maintain awareness of regulatory legislation, assess its business impact and keep management team informed.
- Oversee review and revision of Regulatory Affairs documents.
- Review / revise / approve product labeling, advertising, public communication for compliance to applicable regulatory requirements.
- Support QA in executing compliance activities involving NCMRs, Process Deviations, MDRs to regulatory authorities.
- Lead and mentor junior staff members
- Demonstrated experience in successful regulatory submissions in the US and Internationally.
- Strong project management and leadership skills.
- Strong understanding of various clinical practices in interventional neuroradiology and neurovascular therapies.
- Exceptional public speaking skills to represent corporation at external meetings, conferences and organizations.
- Executes sound judgment, analyzes issues, thinks strategically, creatively, and uses innovative ideas.
- Able to present high level information for multiple audiences.
- Experience organizing and communicating technical information.
- Demonstrates exceptional problem solving, decision-making, conflict management, change management and negotiating skills.
- Excellent written and verbal communication skills.
- Be a results-oriented leader with excellent collaboration and project management skills.
- Possess solid decision-making capabilities with strong expertise of regulatory compliance requirements.
- Minimum of 10 years in Regulatory Affairs or relevant experience.
- Bachelor’s degree in life sciences; M.S. or Ph.D. a plus.
- Certification from the Regulatory Affairs Professional Society is preferred.
- Experience in direct interaction with the FDA.
- Experience with clinical trials, IDEs, 510(k)s, PMAs.
- Knowledge of Microsoft Office packages.