Orthopedics Regulatory Affairs Specialist II

Brighter Signals; West Chester (Chester County); Presencial; USD 76 000 - 122 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Vacation time

Sick time

Parental Leave

Bereavement Leave

Holiday pay

Resumo da oferta

Johnson & Johnson is seeking a Regulatory Affairs Specialist II to execute regulatory activities for DePuy Synthes Joint Reconstruction and VELYS Digital Surgery products across multiple U.S. locations.

The role requires BA/BS with 2+ years in medical device regulatory affairs and solid knowledge of FDA and EU MDR guidelines. You will prepare submissions, assess regulatory impact of changes, and guide cross-functional teams through regulatory paths.

Qualificações

• BA/BS degree with minimum 2 years Regulatory Affairs experience in medical devices.
• Experience with US FDA Regulations and European Medical Device Regulations (and previous Medical Device Directives) required

Responsabilidades

• Prepare and/or assist in preparation of regulatory documentation for DePuy devices, including IDE, 510(k), PMA, Technical File, Design Dossier, and Technical Documentation for submission to regional Health authorities.
• Assist in the preparation of approval documents to support rest of world registrations, such as EU CE marking activities, as required.
• Review engineering changes to currently marketed products and prepare internal regulatory assessments for documenting decisions to submit or not to submit in accordance with relevant regulations and guidance.
• Works with team members to determine regulatory impact of manufacturing and/or changes on products, prepare and submit applications, and the assess the impact product changes have on the status of regulatory licenses.
• Review product labeling and product support information for currently marketed products to ensure that product information and claims are consistent with premarket clearances and approvals and in compliance with relevant regulations and guidance.
• Provides product information and regulatory guidance and support to project teams including processing design control changes, providing guidance and review of promotional materials, and communicating regulatory pathways.
• Maintain current knowledge to ensure compliance to the applicable regulatory and corporate standards/requirements (FDA Quality System Regulations, European Quality Standards and Medical Device Regulation, ISO 13485, previous MDD, MDR, etc.).
• Responsible for communicating business related issues or opportunities to next management level
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
• Performs other duties assigned as needed.

Conhecimentos

Communications

Multitasking

Detail orientation

Medical devices

Electronic submissions

Formação académica

BA/BS degree

Descrição da oferta de emprego

Johnson & Johnson is seeking a Regulatory Affairs Specialist II to execute regulatory activities for DePuy Synthes Joint Reconstruction and VELYS Digital Surgery products across multiple U.S. locations.

The role requires BA/BS with 2+ years in medical device regulatory affairs and solid knowledge of FDA and EU MDR guidelines. You will prepare submissions, assess regulatory impact of changes, and guide cross-functional teams through regulatory paths.