Senior Regulatory Affairs Manager (Onsite)

CorDx is a multi-national biotech organization focused on innovation and supply in global health. The Senior Regulatory Affairs Manager will lead and manage regulatory submissions for medical device products, ensuring compliance with regulations and providing guidance to cross-functional teams.

Requirements

• Master’s degree in Regulatory Affairs, Life Sciences, Engineering, or a related field; advanced degree preferred.
• Minimum of 7-10 years of experience in regulatory affairs within the medical device industry.
• Proven track record of leading and successfully obtaining 510(k) and clearances/approvals.
• Experience in interacting with FDA and other regulatory agencies.
• In-depth knowledge of FDA regulations, 21 CFR Part 820, ISO 13485, and other applicable medical device regulations.
• Strong leadership and project management skills, with the ability to manage multiple projects and priorities.
• Excellent communication, negotiation, and problem-solving skills.
• Ability to work collaboratively in a cross-functional team environment.
• Detail-oriented with strong organizational skills.

Benefits

• Highly competitive compensation package.
• Comprehensive medical, dental, and vision insurance.
• 401(k) plan with generous company contributions.
• Flexible paid time off (PTO) policy.
• Additional substantial benefits.