Job Description

Job Title: Senior Regulatory Affairs Specialist

Job Overview:
We are seeking an experienced and proactive Senior Regulatory Affairs Specialist to lead regulatory submission initiatives and drive compliance strategies in a dynamic medical device environment. This onsite, direct-hire position based in Audubon, PA is ideal for a regulatory professional with a strong technical background, proven submission experience, and the ability to guide and influence cross-functional teams. The role involves independent ownership of submission processes, hands-on documentation, and strategic input into regulatory pathways.

Compensation:

• $100,000-120,000 annually (based on experience)

Work Schedule:

• Monday to Friday, standard business hours

Key Responsibilities of the Senior Regulatory Affairs Specialist:

• Independently draft, manage, and submit 510(k), IDE, and PMA regulatory submissions
• Provide strategic guidance on regulatory requirements and pathways for new and existing products
• Collaborate with internal teams to ensure timely and complete submission content
• Proactively identify regulatory risks and recommend mitigation strategies
• Guide and mentor junior team members, offering technical and procedural insight
• Review labeling and technical documentation to ensure accuracy and compliance
• Support the development and refinement of standard operating procedures (SOPs)
• Maintain and supplement PMA submissions as required
• Demonstrate deep understanding of product systems and their clinical use

Qualifications and Skills for the Senior Regulatory Affairs Specialist:

• Bachelor’s degree in a health, science, or engineering-related field
• 5+ years of experience in regulatory affairs within the medical device industry
• Strong track record of independently preparing and submitting 510(k)s; experience with pre-subs, IDEs, and PMAs
• In-depth knowledge of FDA regulations (21 CFR) and regulatory strategy
• Excellent communication and leadership skills, with the ability to influence cross-functional teams
• Highly organized, self-directed, and capable of handling complex regulatory projects with minimal oversight

Why Join Us?
This is an exceptional opportunity to step into a leadership-focused regulatory role where your expertise will directly impact product success and patient outcomes. Join a collaborative and forward-thinking team that values initiative, continuous improvement, and professional growth. If you're looking to expand your influence in regulatory affairs and drive strategic outcomes, this role offers both challenge and reward in a supportive environment.

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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Job Tags

Contract work, Temporary work, Monday to Friday,

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