Job Title: Regulatory Affairs Specialist

Job Overview:
We are seeking a dedicated and detail-oriented Regulatory Affairs Specialist to support regulatory submissions and compliance efforts within a dynamic medical device environment. This onsite, direct-hire position based in Audubon, PA focuses on preparing regulatory documentation, managing product submissions, and ensuring compliance with FDA regulations. Ideal candidates will have a strong foundation in regulatory affairs, a collaborative mindset, and a desire to grow within the industry.

Compensation:

• $80,000–$90,000 annually

Work Schedule:

• Monday to Friday, standard business hours

Key Responsibilities of the Regulatory Affairs Specialist:

• Draft and submit 510(k), IDE, and PMA submissions in collaboration with cross-functional teams
• Partner with product development and clinical teams to gather and organize content for regulatory submissions
• Prepare and manage Document Change Orders (DCOs)
• Review labeling and technical documentation to ensure regulatory compliance
• Support the development and maintenance of standard operating procedures (SOPs) and staff training
• Maintain PMA submissions and prepare required supplements
• Develop a strong understanding of product systems and their surgical applications

Qualifications and Skills for the Regulatory Affairs Specialist:

• Bachelor’s degree in a health, science, or engineering-related field (Engineering preferred)
•  2–5 years of experience in regulatory affairs within the medical device industry
• Experience preparing 510(k)s, pre-submissions, and familiarity with IDE/PMA processes
• Knowledge of FDA regulations, particularly 21 CFR
• Strong communication and project management skills
• Highly organized, self-motivated, and able to work both independently and as part of a team

Why Join Us?
This is a unique opportunity to join a collaborative team that values initiative, innovation, and professional growth. You’ll have the chance to work on meaningful projects that impact patient care, while gaining exposure to a range of regulatory processes in a fast-paced medical device setting. If you're eager to learn, adaptable, and passionate about regulatory work, this role offers excellent potential for career development.

About Us:
Contemporary Staffing Solutions (CSS) is a trusted leader in providing contract, temporary, temp-to-hire, and direct hire staffing solutions. With decades of experience, we’ve grown from a staffing agency to a nationwide provider of workforce management solutions. Our niche recruitment expertise spans Accounting & Finance, Call Center & Office Support, Human Resources, Sales & Marketing, and Information Technology.

Explore more about CSS and how we connect great talent with exceptional opportunities by visiting www.ContemporaryStaffing.com.

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