Senior Regulatory Affairs Specialist (Columbia, MD)

What will you be doing?

Act as regulatory lead on new HCT/P projects, define regulatory strategy and support project deliverables.

Affords the regulatory impact of changes in HCT/P product specifications, manufacturing process, labeling, and other changes to ensure compliance with FDA 21 CFR 1271 requirements.

Act as NPD regulatory lead on new device-biologics combination products and define regulatory strategy for FDA submissions including authoring FDA 510(k) submissions and FDA pre-submissions.

Reviews and approves advertising and promotional materials for HCT/Ps.

Works collaboratively with cross-functional teams (i.e. Marketing, Legal, Compliance, R&D) to develop and review materials which are compliant with applicable regulations, guidelines, corporate policies and product development objectives.

Participates and supports FDA audits/inspections to maintain all necessary certifications/approvals and ensure compliance with applicable regulations.

Champions a culture of collaboration, leadership, mutual accountability, critical thinking and continuous improvement within a high-performing team.

Represents Regulatory Affairs with excellence in cross-functional interactions and represents Business RA with excellence in interactions with regional RA representatives.

Drafts and maintains applicable policies and procedures supported or owned by the regulatory affairs function.

Stays updated on relevant FDA regulations/guidance’s and provides notice and summary of the impacts of any changes to the regulatory landscape to the business.

What will you need to be successful?

• Bachelor’s degree in Chemistry, Biology, or a related scientific discipline.
• Regulatory Affairs Certification (RAC Devices) preferred.
• Minimum of 5 years of hands-on experience in Regulatory Affairs.
• Proven experience supporting and/or leading FDA 510(k) submissions and Pre-Sub meetings (Q-Subs).
• Experience and working knowledge of HCT/Ps (21 CFR 1271) highly desired.
• Demonstrated experience liaising directly with the FDA, including serving as the regulatory lead in Agency interactions for Pre-Subs and 510(k) submissions.
• Deep regulatory expertise within relevant therapy areas, including HCT/Ps and device-led combination products.
• Ability to work strategically within complex, business-critical, and high-visibility programs.
• Strategic and critical-thinking skills, with the ability to proactively identify and evaluate regulatory risks.
• Demonstrated initiative, strong work ethic, and excellent oral and written communication skills, with the ability to influence cross-functional partners effectively.

Pay

The anticipated base compensation range for this position is $101,500.00 to $152,250.00 USD annually.

Benefits

• Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually)
• Employee Assistance Program
• Parental Leave
• Generous PTO
• Paid Company Holidays
• 8 hours of volunteer time annually
• A variety of wellness offerings such as EAP