Job Description

About Teleflex Incorporated Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people\xe2\x80\x99s lives. We apply purpose driven innovation \xe2\x80\x93 a relentless pursuit of identifying unmet clinical needs \xe2\x80\x93 to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit teleflex.com.
Global Operations - Global Operations is a complex and diverse organization within the company which is responsible for product fulfilment to all our customers from end to end. We pride ourselves on being totally Customer Centric in our unrelenting focus on Improving Quality, Service and Value as perceived by our customers. Our employees are dedicated to the Global Operations Enterprise Excellence journey. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients\xe2\x80\x99 lives.

Position Summary

Principal Responsibilities

1. Overseeing preparation of product registration documents and product tender applications for submission to global product registration groups.
2. Review and evaluate technical and scientific data and reports and incorporate them into documents for submission to the US-FDA, EU-NB, Health Canada and other foreign regulatory agencies.
3. Review and evaluate change impact on US 510(k), license in Health Canada, MDD Technical File, and product registration in various countries. Prepare regulatory strategy.
4. Review transfer product project impact on 510(k), license in Health Canada, MDD Technical File, and product registered in various countries for transfer products. Prepare regulatory strategy.
5. Review and approve product labelling to ensure compliance to US-FDA, EU-MDD, Health Canada and other foreign regulatory agencies, and UDI requirements.
6. Apply for new Health Canada license and amend existing licenses as requested.
7. Maintenance of updated and revised standards to support compliance of Teleflex Medical product.
8. Participate in R&D projects, changes to existing products and processes and other regulatory /company projects as required. Prepare regulatory strategy.
9. Update and maintain regulatory database.
10. Review and approve marketing pieces i.e. brochures
11. Review and approval of validation protocols/reports and change requests.
12. To comply with requirements of Occupational Safety and Health Act 1994 and other legislative requirements in the workplace.

Education / Experience Requirements

Qualification : Bachelor\xe2\x80\x99s Degree in Engineering or equivalent Experience : Minimum 2 years Quality System or Regulatory experience in medical device industry.

Specialized Skills / Other Requirements

Note: As with all positions, due to the dynamic nature of Teleflex Medical business, key responsibilities may evolve and change over time. Teleflex is an equal opportunities employer