We are seeking an experienced Senior Regulatory Affairs Specialist to support the review and approval of advertising and promotional materials for medical device products in the U.S. market. The successful candidate will represent Regulatory Affairs on global and regional Promotional Review Committee (PRC) and Scientific Review Committee (SRC) teams, ensuring promotional materials comply with FDA regulations, company policies, and applicable industry standards. This individual will independently evaluate promotional content, provide clear regulatory guidance to cross-functional stakeholders, and help drive compliant product commercialization.
Responsibilities
Represent Regulatory Affairs on global and regional Promotional Review Committee (PRC) and Scientific Review Committee (SRC) meetings.
Independently review advertising, promotional, digital, print, social media, sales training, and commercial materials intended for the U.S. market.
Ensure promotional communications comply with FDA regulations, applicable guidance documents, company policies, and internal procedures.
Evaluate promotional claims, product messaging, scientific substantiation, labeling consistency, and risk-benefit communications.
Translate complex regulatory requirements into practical, decision-ready guidance for Marketing, Medical Affairs, Legal, Clinical, and Commercial teams.
Identify regulatory risks and recommend compliant solutions while supporting business objectives.
Collaborate with cross-functional stakeholders throughout the promotional material development and approval lifecycle.
Maintain documentation supporting regulatory review decisions and promotional compliance.
Monitor changes in FDA advertising and promotion regulations, guidance documents, and industry best practices.
Provide regulatory expertise during product launches, lifecycle management activities, and promotional campaigns.
Support internal audits, compliance initiatives, and inspection readiness activities as needed.
Mentor junior team members and contribute to continuous process improvements within the promotional review process.
Required Qualifications
Bachelor's degree in Life Sciences, Pharmacy, Biomedical Engineering, Regulatory Affairs, or a related scientific discipline.
Minimum 5 years of direct experience reviewing advertising and promotional materials for the U.S. market.
Experience representing Regulatory Affairs on Promotional Review Committee (PRC) and/or Scientific Review Committee (SRC) teams.
Strong knowledge of FDA advertising and promotional regulations for medical devices. Relevant pharmaceutical advertising and promotional review experience will also be considered.
Demonstrated ability to independently review promotional materials and make sound regulatory decisions with minimal supervision.
Experience interpreting FDA regulations, guidance documents, and promotional compliance requirements.
Excellent analytical, communication, negotiation, and stakeholder management skills.
Ability to effectively collaborate with Marketing, Medical Affairs, Legal, Clinical, and Commercial teams in a fast-paced environment.