Job Title: Lead Regulatory Affairs Specialist

Job Overview:
We are seeking a highly skilled and strategic Lead Regulatory Affairs Specialist to play a pivotal leadership role within a collaborative medical device regulatory team. This onsite, direct-hire position based in Audubon, PA is ideal for a seasoned professional with deep regulatory expertise and a passion for mentoring others. While this role does not have direct reports, it serves as an unofficial team lead, supporting strategic initiatives, guiding submission execution, and providing oversight on complex projects. This is a prime opportunity for a candidate seeking to grow into a future people management role.

Compensation:

• $130,000–$135,000 annually

Work Schedule:

• Monday to Friday, standard business hours

Key Responsibilities of the Lead Regulatory Affairs Specialist:

• Serve as a key regulatory leader supporting overall team strategy and submission planning
• Independently lead and oversee complex regulatory submissions, including 510(k), IDE, and PMA applications
• Mentor and guide junior team members, providing hands-on support and professional development
• Review and approve submission components, ensuring accuracy, compliance, and alignment with regulatory strategy
• Collaborate with internal stakeholders to identify submission needs, regulatory risks, and opportunities for process improvement
• Partner with leadership to shape regulatory pathways and team priorities
• Maintain deep knowledge of FDA regulations (21 CFR) and industry trends to inform strategy and execution
• Take ownership of submission timelines and deliverables, ensuring proactive issue resolution and continuous progress

Qualifications and Skills for the Lead Regulatory Affairs Specialist:

• Bachelor’s degree in a health, science, or engineering-related field 
• 7+ years of experience in regulatory affairs within the medical device industry
• Demonstrated experience mentoring or leading team members (formally or informally)
• Proven success owning and submitting complex regulatory submissions (510(k), IDE, PMA)
• Advanced understanding of FDA regulations and regulatory strategy
• Strong leadership presence with the ability to influence, coach, and guide peers
• Highly motivated, organized, and capable of balancing hands-on submission work with strategic oversight

Why Join Us?
This is an exciting opportunity to take on a leadership role in regulatory affairs without immediate people management responsibilities—ideal for someone who enjoys guiding others and leading initiatives while still staying hands-on. You’ll support senior leadership in team oversight and drive submission strategies that contribute directly to product and company success. If you’re ready to lead with impact and evolve into a future management role, this position offers the perfect next step in your regulatory career.

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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