Senior Regulatory Affairs Associate Leeds, England
Job description
DePuy Synthes is recruiting for a Senior Regulatory Affairs Associate (m/f/d) , located in Leeds or Blackpool, UK.
The Senior Regulatory Affairs Associate will execute regulatory activities to support currently marketed devices and new product development in the DePuy Synthes Joint Reconstruction line of products. This role involves a multi-faceted set of skills including sound regulatory judgment, cross-functional collaboration, and planning/oversight/execution of projects & activities that directly impact the operational results of the business!
DePuy Synthes , part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.
Key Responsibilities:
- 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. This includes the resolution of regulatory issues and questions from regulatory agencies during the pre-market product development phase and interacting with regulatory agencies regarding submissions
- Responsible for preparing original STEDs, EU technical files, design dossiers, technical documentation and technical file and documentation revisions for the Global market
- 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
- Obtains approval of new products and provides regulatory requirements to help ensure efficient use of project resources
- 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
- Serves as a consultant and technical expert on Regulatory Affairs matters
- Aids in preparation and submission of global regulatory documents
- Responsible for communicating business related issues or opportunities to next management level
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
- Performs other duties assigned as needed
Qualifications
Education:
- BA/BS Degree required; advanced degree or equivalent work experience preferred
Experience and Skills:
Required:
- Demonstrated expertise in medical device regulatory requirements and processes
- Experience with US FDA Regulations and European Medical Device Regulations (and previous Medical Device Directives) required
- Outstanding written and oral communication skills
- Outstanding project management skills by demonstrated competence in managing multiple projects simultaneously
- Capable of providing direction and training to junior colleagues
Preferred:
- Experience in worldwide regulatory systems
- Demonstrated expertise in orthopaedics and orthopaedic device regulatory requirements
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We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences
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