Sr. Regulatory Affairs Specialist

Cellicor | a THG Company; Philadelphia (Philadelphia County); On-site; USD 110,000 - 120,000; Full time

Job summary

A leading company in the medical device sector is seeking a Sr. Regulatory Affairs Specialist in the Philadelphia area. This fulltime, permanent role involves regulatory submissions and compliance for Class 2 and 3 medical devices. The position offers competitive compensation, healthcare benefits, and a relocation package if needed.

Benefits

Full healthcare benefits

PTO package

401K

Qualifications

• 4+ years of Regulatory Affairs experience in medical devices.
• Experience preparing and clearing 501(k) submissions.
• Working knowledge of FDA guidelines.

Responsibilities

• Assist in drafting and preparing regulatory submissions.
• Work closely with Class 2 and 3 medical device products.
• Ensure timely compliance with FDA guidelines.

Skills

Regulatory Affairs Experience

Understanding of FDA guidelines

Experience with Class 2 and 3 Medical Devices

Job description

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Cellicor is seeking to hire a Sr. Regulatory Affairs Specialist for a Medical Device company in the Philadelphia, PA area.

**This is a fulltime, permanent, onsite opportunity. Out of state relocation package is available**

Qualifications for the Sr. Regulatory Affairs Specialist:

• 4+ years of progressing Regulatory Affairs experience within the medical device space.
• Experience preparing and clearing 501(k) submissions
• Experience working closely with the FDA
• Experience working within product development. Biologics experience a plus but not required.
• Prior experience working closely with Class 2 and 3 Medical Devices.

Responsibilities for the Sr. Regulatory Specialist:

• Assist in the drafting, preparation and clearance of submissions
• Working with Class 2 and 3 medical device products
• Awareness of recent FDA relative guidelines for class 2 and 3 devices and timely responsiveness to FDA

Compensation for the Sr. Regulatory Specialist:

• $110,000-$120,000/year
• Full healthcare benefits
• PTO package
• 401K

Keywords:

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Science

• Industries

  Medical Equipment Manufacturing

Referrals increase your chances of interviewing at Cellicor | a THG Company by 2x

Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

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