Hzy74 | Regulatory Affairs Specialist Ii

hace 2 días

León, España Ares Consultores A tiempo completo

.Medical Device Business Services, part of Johnson & Johnson MedTech, is recruiting for a Regulatory Affairs Specialist II to support our Sports Orthopedics business.
The preferred location for this role is Raynham, MA, West Chester, PA, or Oberdorf, CH.
However, candidates may also be located within a commutable distance of offices in Palm Beach Gardens, FL, Leeds, UK, or Lyon/Grenoble, FR.
This role will follow a Flex/Hybrid schedule with 3 days per week in office.
There is NO remote option.
About Johnson & Johnson: At Johnson & Johnson, we believe health is everything.
Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.
Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity.
The Regulatory Affairs Specialist II provides regulatory guidance to project teams in business planning and related submissions to support DePuy Synthes Arthroscopic Equipment Solutions products.
Under minimal direction, the individual develops and performs regulatory strategies for significant change supplements and 510(k) registrations to support the continued commercialization of products in key countries.
This role helps define the data and information needed for regulatory actions in conjunction with cross-functional teams.
In addition, this candidate guides conformance with applicable regulations through the development of standard methodologies for Regulatory Affairs processes, procedures, and systems.
Key Responsibilities Prepares responses to regulatory agencies' questions and other correspondence.
Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines.
Researches and collects data and responds to requests from regulatory agencies and/or distributors to prepare and submit documentation for marketing approvals, as well as to provide routine regulatory information to associates and affiliates.
Advises on regulatory labeling requirements and specifications for modified products, and reviews product labeling to ensure compliance.
Provides regulatory guidance and mentorship to project teams and responds to product information requests.
Provides Regulatory Affairs support during internal and external audits.
Assists in the development of standard methodologies for Regulatory Affairs processes.
Responsible for communicating business-related issues or opportunities to the next management level and represents Regulatory Affairs on cross-functional project teams.
Responsible for following all company guidelines related to health, safety, and environmental practices, as applicable

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