Specialist Medical Device Development

New position - Maternity leave replacement 

JUBILANT DRAXIMAGE INC. DBA JUBILANT RADIOPHARMA, RADIOPHARMACEUTICALS DIVISION, is currently recruiting for a Specialist Medical Device Development position to join our growing team!

What can we offer?

A culture that values opportunity for professional growth and development,highly competitive base pay, comprehensive medical, dental and disability benefits programs, group retirement savings program, health and wellness programs.

Jubilant DraxImage Inc. is a rapidly growing company with offices in Kirkland, QC and Yardley, PA. A global leader in the development of radiopharmaceuticals and state-of-the-art technologies, we are continuously seeking high caliber professionals to join our team. Jubilant DraxImage is a proud member of the Jubilant Pharma family. For more information, visit www.draximage.com

We will, with the utmost care for the environment and society, continue to enhance value for our customers and stakeholders by providing innovative products and economically efficient solutions' through growth, cost effectiveness and wise investment of resources.

If you're up for a rewarding challenge, we invite you to take the first step and apply today!

Jubilant Pharma Holdings Inc and all our subsidiaries proudly embraces diversity in our workforce. Our goal is to have a workforce as diverse as the patients and clients we serve. We have an inclusive environment where our employees can thrive and where our differences are welcomed. By welcoming our differences, we create products that are beneficial for our patients, clients, and overall human health.

Summary 
 

The Specialist Medical devices development plays a vital role in developing safe and effective medical devices at JDI. As an embedded member of the Medical Device Development Team (MDDT), they support the rapid and efficient development of new products, while ensuring that complete and transparent records of the development process are created. They will be responsible for the definition and evolution of Design Control related processes at JDI. They will be the process gatekeeper and will maintain Design Control and Risk Management systems and files for all medical device development projects.

The Specialist works closely with a team of engineers, scientists and other professionals in developing highly innovative products for use in clinical setting. Their work helps safeguard the integrity of the design and ensures that the Design History Files (DHF) meets all regulatory requirements. The Specialist is expected to bring to their role a passion for proper design control methodology, a strong sense of pride in their work output, and a real interest in JDI's technology, products, and application.

Responsabilities

• Defines and Maintains Design Controls system as per 21 CFR 820.30 and ISO 13785.
• Defines and Maintains Risk Management system as per ISO 14971: 2012.
• Defines and Manages change request process
• Co-ordinates Design History File (DHF), Risk Management Files (RMF) and Device Master Records (DMR) creation.
• Maintains centralized Design History Files (DHFs), Risk Management Files (RMFs) Technical files and Device Master Records (DMRs).
• Establishes and maintains Traceability matrices.
• Reviews all DHF documents to ensure quality and completeness.
• Mentors team members on Design Control and Risk Management principles.
• Supports team members in the implementation of Design Control processes.
• Defines development pathway for all device development projects.
• Co-ordinates completion of CCs associated with intro of new device or design change to a device
• Be the mentor for team members in the principles of design control and risk
• Performs additional duties as assigned by Management

Requirements

• Bachelors in science or equivalent
• Minimum of 5 years of experience in medical device development for US and EU markets
• Experience in quality assurance is an asset.
• Excellent understanding of Design Control processes and Risk Management. 
• Familiar with Good Manufacturing Practices (GMP) for medical devices.
• Bilingual with excellent communication skills and written English.
• Computer skills are required such as Microsoft Office™ are required
• The holder is a person who is self-motivated, organized and attentive to detail.
• Must be able to work independently or in a team.