Regulatory Affairs Manager- Senior
Location: Manchester, NHType: Full Time Min. Experience: Manager/Supervisor
DEKA employs a team of over six hundred professionals, whose engineering, design, manufacturing and quality expertise make DEKA a hot spot for creating innovative solutions and advanced technologies. Located about an hour from Boston, the beach, and the mountains, DEKA is one of the leading research and development companies in the country and is the birthplace of some of the most innovative and life-changing products of our time.
We have an exciting opportunity for a Senior Manager of Regulatory Affairs to work in a dynamic medical device R&D environment. This senior management position plays a vital role in the success of our products. This is a great opportunity to utilize your solid technical capabilities and leadership skills to guide a Regulatory team for products that truly make a difference. Interested? We'd love to hear from you.
The Senior Manager of Regulatory Affairs will help lead DEKA’s regulatory group and product development efforts in obtaining the appropriate regulatory approvals to conduct clinical studies from FDA, IRBs and/or Ethics Boards. The ideal candidate will initiate and conduct FDA meetings, teleconferences, and other agency communications as needed. As the senior regulatory person, this individual will be a critical liaison between DEKA and our customers on matters of a regulatory nature.
How you will make an impact:
Working as a team member to lead the regulatory group,
Directing the strategic planning for US and international regulatory efforts including planning and obtaining regulatory approvals in the US, EU, and working with other non-CE countries’ regulatory authorities as needed
Ensuring regulatory applications comply with applicable regulations and guidance documents
Preparing and submitting regulatory applications, including 510(k)s, PMAs, IDEs, CE applications, etc.
Qualities we are seeking:
Candidates must have a minimum of 10 years direct work experience in a regulatory role and demonstrated success in obtaining regulatory approvals.
Candidates must have, at minimum, a BS degree in a technically related field.
Knowledge of FDA’s Quality System Regulations (QSRs)
International medical device experience including knowledge of device CE marking requirements, and associated experience is desired.
Must have experience with submitting 510K, IDE or PMA
Prior start up experience a plus!
Prior experience with medical devices, electro-mechanical and or fluidic drug delivery products.