HireDiversity

Miramar, FL, US

Regulatory Affairs Specialist II-8420120627

Description

DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies will offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, we are creating one organization that will be agile and better equipped in today's evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.

Codman & Shurtleff is the Neurological business focused on neurosurgery, neurovascular and neuromodulation, offering a broad portfolio of solutions including programmable shunt systems, catheters, trauma monitoring devices, drug pumps, neurovascular coils, liquid embolics and vascular reconstruction devices.

The Regulatory Affairs Specialist II will prepare EU and US submissions including traditional, or special 510(k)s and EU Technical Files and Design Dossiers updates and notifications. This individual will provide regulatory support to product manufacturing transfers. This individual will provide regulatory support for product design, manufacturing, packaging, sterilization, and labeling changes. The Regulatory Affairs Specialist II will review and provide regulatory authorization for Engineering Change Orders (ECOs). This individual will also review and analyze technical data generated by Research and Development, Marketing/Sales, Clinical Research, Quality Assurance or other related departments. This individual will work with Management to develop appropriate regulatory strategies.

Qualifications


A minimum of a Bachelors degree is required. A focused scientific degree is preferred. A minimum of 2 years in a Regulatory Affairs function in a highly regulated industry is required. Experience preparing submissions for Class II/III medical devices is required. Specific experience in the preparation, and submission of 510(k)'s, or PMA supplements and Technical Files or Design Dossiers is required. International regulatory affairs experience outside of the US, specifically EU regulatory requirements is preferred. Understanding of FDA regulations is required.

Excellent written and verbal communications skills and the capability of working independently and in a team setting is required. Ability to work and communicate in a cross-cultural team environment is required. Strong analytical thinking, problem solving and investigative skills are required. The ability to manage multiple requests simultaneously with strong attention to detail is required.

This position requires up to 10% domestic and international travel. This position will be based in Miami, Florida, with consideration for the role to be based in Raynham, Massachusetts.

BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location:North America-United States-Florida-Miramar
Organization: Depuy Orthopaedics. Inc. (6029)