Senior Regulatory Affairs Specialist

Integrated Resources Inc.; West Chester (Chester County); On-site; USD 80,000 - 110,000; Full time

Job summary

A prestigious staffing firm seeks a Senior Regulatory Affairs Specialist for their client in West Chester, PA. The role focuses on managing regulatory activities and field actions in the medical device sector. The ideal candidate must have significant experience and a relevant educational background, and possess excellent communication and analytical skills.

Qualifications

• 4+ years of experience in medical device/pharmaceutical industry.
• 1+ year in a regulatory role required.
• Experience with field action activities preferred.

Responsibilities

• Lead OUS field action execution and manage team meetings.
• Prepare documents for regulatory agencies and customer communications.
• Provide updates to FDA and close Field Actions timely.

Skills

Analytical problem solving

Root cause analysis

Excellent communication skills

Education

Bachelor’s Degree in Engineering or Technical Science

Advanced Degree

Tools

PowerPoint

Word

Excel

Job description

A Few Words About UsIntegrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

Job Description

Client: Direct Client

Location: West Chester, PA

Job Title: Senior Regulatory Affairs Specialist

Duration: 1 year + (Possible Extension)

Job Summary:

The Recall Regulatory Specialist III will be responsible for leading OUS (outside the US) field action execution activities including managing Field Action Strategy Team meetings, coordinating and preparing document packages to notify regulatory agencies of field action activities, drafting internal and external customer communications, providing updates to FDA and global regulatory agencies, processing and closing Field Actions in a timely manner, and act as support for FDA and regulatory inspections.

Responsibilities:

• Working knowledge of 21 CFR Part 820, QSR, ISO 13485, CFR 806, and MDD/IVDD requirements is preferred.

• The ability to work autonomously and on multiple projects with accelerated timelines is required.

• Proven experience leading projects with cross-functional teams is required.

• Proven ability to meet timelines is required.

• Excellent Investigative skills such as analytical problem solving, fish bone, root cause analysis, etc. is preferred.

• Excellent computer (e.g., PowerPoint, WORD, Excel, Vision) communication, and written skills are required.

Qualifications

Education

• A minimum of a Bachelor’s Degree in Engineering or Technical Science is required.

• Advanced Degree is preferred.

• A minimum of 4+ years of experience in a medical device and/or pharmaceutical industry, and 1+ year within a regulatory role is required.

• Experience with field action related activities is preferred.

Additional Information

Feel free to forward my email to your friends/colleagues who might be available

Thanks!!!

Warm Regards,

Amrit Singh

Clinical Recruiter

Integrated Resources, Inc.

IT REHAB CLINICAL NURSING

Tel: [phone] (Direct)

Ext: [phone] x (212)

Fax: [phone]

http://www.irionline.com

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