Johnson & Johnson Careers
Regulatory Affairs Specialist Medical Devices
Wokingham, United Kingdom
Requisition ID: 1905708610W
At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s largest and most broadly based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, build healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere.
Every single day, our more than 130,000 employees across the world are blending heart, science and ingenuity to deeply change the trajectory of health for humanity.
Main purpose of job
We are looking for a regulatory affairs specialist in the medical device sector within the medicine and human tissue therapeutic area. You will ensure we meet Regulatory Requirements in the UK/IRL whilst ensuring that J&J Standards are compleated on-time. You will be competent with copy review in both print and web media.
•Inventory and regular updates and communication of RA requirements
•Documenting and updating advertising requirements
•Keeping updated information on translation requirements for IFU's, Internet sites
•Monitoring of local Regulatory Environment and feed-back to relevant partners
•Ensuring Product Portfolio is in compliance with national legislation
•Ensuring organization compliance with all applicable regulations and policies and standard requirements
•Monitoring RA targets, ensure effective flow down and performance
•Driving accountability for RA compliance to foster a compliance driven culture
•Assisting with establishing corrective & preventive actions to mitigate potential or actual non-compliance risk
•Ensuring on-time submissions and approvals
•Ensuring local licenses are in place – particularly Human Tissues License
•Ensuring RA knowledge in MD, and other defined regulatory knowledge as necessary for the business through industry publications and seminars.
Do you have the following skills, experience and knowledge?
•You have excellent written and oral English communication skills
•You have indepth Knowledge of Medical Device or Pharma regulations.
•Strong collaboration skills and you are able to build partnerships internally and externally
•You are capable of influence others and have interpersonal skills
•Further education in Pharma, Law, Bioscience, Engineering or Business or equivalent field coupled with relevant business experience in Regulatory roles.
•Are you confident in your knowledge of EMEA national medical device regulations?
•you have an understanding of ISO 9001 Standard. Process Excellence experience with ISO 13485 or equivalent quality standards.
•Are you currently working in industry ? with 1 – 2 years experience in a regulatory role within an International Medical Device Company
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Johnson & Johnson Medical Ltd. - fka -Ethicon Ltd. (7355)