Senior Manager, Regulatory Affairs - Medical Devices

MTF Biologics; Edison (NJ); On-site; USD 99,000 - 125,000; Full time

Benefits offered by this job

4 weeks Paid Time Off (PTO)

401K plan with company match

Medical, Dental, Vision Insurance

Tuition Reimbursement

Job summary

MTF Biologics, located in Edison, New Jersey, is seeking a Regulatory Affairs Manager to oversee regulatory functions and ensure compliance with U.S. and international regulations. Responsibilities include leading a team, managing submissions, and developing regulatory strategies for new products.

The ideal candidate will have over 7 years of experience in regulatory affairs, with a bachelor's degree in a scientific field and proven managerial skills. The role offers a competitive salary with a comprehensive benefits package, including paid time off and health insurance.

Qualifications

• 7+ years of overall experience.
• 5+ years of managerial experience.
• 5+ years in human tissue or medical device manufacturing.
• Thorough understanding of ISO regulations.

Responsibilities

• Lead and develop Regulatory Affairs staff.
• Assist in managing the budget for the department.
• Oversee regulatory submissions for U.S. and international markets.
• Ensure maintenance of applicable licenses and certifications.
• Communicate with regulatory agencies on standards and regulations.

Skills

FDA regulations

People management

Communication skills

Problem-solving

Attention to detail

Education

Bachelor's degree in a scientific or related field

Job description

MTF Biologics, located in Edison, New Jersey, is seeking a Regulatory Affairs Manager to oversee regulatory functions and ensure compliance with U.S. and international regulations. Responsibilities include leading a team, managing submissions, and developing regulatory strategies for new products.

The ideal candidate will have over 7 years of experience in regulatory affairs, with a bachelor's degree in a scientific field and proven managerial skills. The role offers a competitive salary with a comprehensive benefits package, including paid time off and health insurance.