Regulatory Affairs USA
- Reference: JLSRAUS
- Location: Carmarthen
- Salary: £40000 Plus
- Type: Full time
Do you wish to be part of a business which expanding rapidly and manufacturing a Healthcare Product that is changing peoples lives for the better? This revolutionary Med Tech business is seeking a number of highly skilled people one of these is for a Regulatory Affairs North America.
The person will be directly involved with the management of regulatory projects, including, but not exclusively, new product development, product life cycle and regulatory processes. There will be a focus on developing premarket submissions/ design dossiers for products intended to be marketed in the United States of America and Canada
Qualifications, Skills and Experience
• To prepare, submit and facilitate Class II Sl0(k) submissions in accordance with the FDA's Code of Federal Regulations, Title 21.
• To prepare, submit and facilitate Class II and Class Ill Health Canada submissions in accordance with the Canadian Medical Device Regulation SOR 98-282.
• Maintain each cleared Sl0(k) fillings following changes to product, process or labelling.
• Maintain each cleared Medical Device Licence (MDL) following changes to product, process or labelling.
• To liaise directly with international regulatory agencies and provide supporting documentation, handle queries and issues
• Offer general advice on regulatory strategy for new product developments, product re development and process changes
• To contribute to the development and implementation of regulatory policies, procedures and specifications across the company and ensuring that these are compliant with the Quality Management System.
• To assist with the regulatory compliance of marketing communications/messages products and services.
• Monitor changes in legislation, standards and guidance documents .
• Contribute to the development and implementation of regulatory policies, procedures and specifications across the company and ensuring that these are compliant with the Quality Management System.
• To be responsible for planning own workload and works with limited input from the line manager, influencing personal training and assisting in setting appropriate time lines for projects.
• To follow and promote Company, HS&E and Quality procedures and standards to enable the site to achieve and maintain excellent results.
• Any other reasonable duties commensurate with the skills and responsibility of the post holder.
• To promote and adhere to the workplace values of HWYL:
o Honesty, integrity and respect for others
o Willingness to accept challenges and responsibility
o Your commitment to our customers and business growth
o Learn and develop.
- PERSON SPECIFICATION
- SKILLS AND ABILITIES
• Able to understand standards and regulations and how
they apply to medical devices.
• Able to remain calm in high pressure situations, i.e. during audits.
• Able to communicate effectively including different countries and cultures.
• Able to assimilate information quickly.
• Attention to detail.
• IT literate - Microsoft Office expertise.
• A scientific, medical or engineering background.
• At least 4 years Regulatory Affairs experience.
experience the person would need to do
• Previous experience submitting 510(k) submissions to the
• Previous experience Submitting Class II and Class Ill Medical Device Licence applications to Health Canada.
• Experience operating in an ISO 13485 and 21 CFR.820 certified Quality Management System.
• Knowledge of FDA 21 CFR 820, specifically Parts 807 and 814.
• Knowledge of the Canadian Medical Devices Regulation
SOR/ 98- 282.
• Knowledge of ISO 13485 and 21 CFR 820 Quality Management Systems
• Knowledge of ISO 14971 Risk Management of Medical Devices.
• Able to work alone and as part of a team
• Willingness to learn
- Interested then please email firstname.lastname@example.org or call 07968 551450
Just Life Sciences
< Back to jobs list