Director of Regulatory Affairs and Quality

Saladax Biomedical is a leading Personalized Medicine company located in the Lehigh Valley of Pennsylvania. Saladax develops, manufactures and markets in vitro diagnostic reagents for oncology and neurology drug dose management in Bethlehem, PA.

We currently have an open staff position to head the Regulatory Affairs, Quality and Clinical areas. The Director of Regulatory, Quality and Clinical will be responsible for establishing regulatory strategies for novel IVDs, preparation and submission of required regulatory documentation to support product approvals / clearances with US FDA and other regulatory agencies around the world, as well as transitioning the organization to compliance with the IVDR. The Director will ensure that the Saladax manufacturing site is appropriately registered, and devices are listed and notified as applicable. The Director will work with R&D, Operations and Marketing during development to identify regulatory requirements and approve literature and promotional material.

The Director will also be responsible for the implementation and maintenance of a Quality System that is in compliance with 21 CFR Part 820, ISO 13485:2016, and with all federal, state, local and international requirements, including the EU and regions under MDSAP. As the Management Representative, the Director of Quality, Regulatory and Clinical has full authority for the establishment, implementation, maintenance, and effectiveness reporting of quality system activities, hosting site related audits, and vigilance activities.

Other responsibilities include planning, execution and document management related to all clinical studies with direct oversight of all clinical research organizations and clinical contractors performing work related to those clinical studies.

Requirements: Minimum B.S. degree in a Quality or a scientific discipline and/or engineering, five years’ experience in Quality assurance and Regulatory management in a medical device related environment, and knowledge of GCPs is required. This position will require on-site presence.

Interested candidates can e-mail their resume and cover letter to positions@saladax.com.

Saladax offers competitive compensation including equity participation and benefit programs. Saladax is an equal opportunity employer.

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Stock options
• Vision insurance

Schedule:

• Monday to Friday

Work Location: In person