Regulatory Affairs Project Manager

• Work in close association with customers and development teams to define and execute regulatory approval and clearance programs including establishing regulatory requirements and leading the preparation and submission of 510(k)s PMAs IDEs Technical Files and other international dossiers
• Provide leadership and guidance to R&D in developing successful regulatory strategies across the entire product life cycle
• Mentor regulatory affairs staff as well as internal cross-functional partners on effective regulatory strategies and tactics
• Lead FDA interactions including in-person meetings teleconferences written submissions and other Agency engagements as needed
• Participate in the design and conduct of clinical trials and assist in obtaining and maintaining the appropriate regulatory approvals from the FDA IRBs and/or Ethics Boards
• Continually improve internal regulatory processes and procedures to increase efficiency and reduce time to market while maintaining the highest levels of compliance

• BS in a technically related field
• Minimum of 5 years direct work experience in a medical device drug or biologic regulatory role with demonstrated success in obtaining product approvals/clearances
• Experience in direct FDA interactions including premarket notifications IDEs Q-submissions and participation in face-to-face meetings
• Strong written and verbal communication skills
• Demonstrated ability to continually balance priorities in a dynamic and fast-paced environment
• Expertise in current FDA processes including the eSTAR submission tool establishment registration and listing UDI product labeling and post-market reporting including MDRs and Field Action Reporting
• Experience in Medical Device Quality Regulations including Quality Management Systems Regulations (QMSRs) ISO 13485 and MDSAP
• Demonstrated ability in expanding regulatory organization capabilities
• Experience with drug biologic and combination product approvals a plus
• RAC certification a plus

About DEKA:

One hour from the beach Boston and the mountains the historic Amoskeag Millyard once housed the largest textile mills in the world. It is now home to DEKA Research and Development where we are taking the same innovation and cutting-edge technology into the modern age.

Behind DEKAs brick walls sits a team of professionals who strive to make a difference every day through thoughtful engineering design and manufacturing. Here at DEKA some of the most innovative and life-changing products of our time are created and new ideas are always welcome and explored.