DEKA Research & Development has an immediate opening for a Regulatory Affairs Project Manager to contribute to a dynamic medical device research and development environment. The role is on-site in Manchester, New Hampshire, United States, and involves delivering regulatory strategies to obtain FDA approvals or clearances as well as international clearances such as CE marking.

As Regulatory Affairs Project Manager, you will define and execute regulatory programs with customers and development teams, establish regulatory requirements, and lead the preparation and submission of 510(k)s, PMAs, IDEs, Technical Files, and other international dossiers. You will provide leadership to R&D in developing regulatory strategies across the product lifecycle, mentor regulatory staff and cross-functional partners, and lead FDA interactions including in-person meetings, teleconferences, and written submissions. You will participate in the design and conduct of clinical trials and help obtain and maintain regulatory approvals from the FDA, IRBs and Ethics Boards. You will continually improve internal regulatory processes to increase efficiency and speed to market while maintaining the highest levels of compliance.

Qualifications: BS in a technically related field; at least 5 years of direct regulatory experience in medical devices, drugs, or biologics with demonstrated success in obtaining approvals/clearances; experience with direct FDA interactions including premarket notifications, IDEs, Q-submissions, and in-person meetings; strong written and verbal communication skills; ability to ba

DEKA Research & Development has an immediate opening for a Regulatory Affairs Project Manager to contribute to a dynamic medical device research and development environment. The role is on-site in Manchester, New Hampshire, United States, and involves delivering regulatory strategies to obtain FDA approvals or clearances as well as international clearances such as CE marking.

As Regulatory Affairs Project Manager, you will define and execute regulatory programs with customers and development teams, establish regulatory requirements, and lead the preparation and submission of 510(k)s, PMAs, IDEs, Technical Files, and other international dossiers. You will provide leadership to R&D in developing regulatory strategies across the product lifecycle, mentor regulatory staff and cross-functional partners, and lead FDA interactions including in-person meetings, teleconferences, and written submissions. You will participate in the design and conduct of clinical trials and help obtain and maintain regulatory approvals from the FDA, IRBs and Ethics Boards. You will continually improve internal regulatory processes to increase efficiency and speed to market while maintaining the highest levels of compliance.

Qualifications: BS in a technically related field; at least 5 years of direct regulatory experience in medical devices, drugs, or biologics with demonstrated success in obtaining approvals/clearances; experience with direct FDA interactions including premarket notifications, IDEs, Q-submissions, and in-person meetings; strong written and verbal communication skills; ability to ba