Senior Regulatory Affairs Associate - Leeds, United Kingdom - Johnson & Johnson

Johnson & Johnson

Verified Company

Leeds, United Kingdom

3 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

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

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 premarket 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
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

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day.

Our commitment to respect the dignity and diversity of all is embedded in our Credo.

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

That is why we in
England are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential.

No matter who they are.

Diversity, Equity & Inclusion at Johnson & Johnson means "You Belong"