Senior Regulatory Affairs Specialist
New
Senior Regulatory Affairs Specialist based in United States.Full-TimeSenior
Salary not disclosed
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Job Details
- Experience
- Minimum of 4 years
- Required Skills
- Risk Management
Requirements
- Bachelor’s degree in Biology, Biochemistry, Microbiology, or a related scientific field.
- Minimum of 4 years of regulatory affairs experience in a FDA- and ISO-regulated environment.
- Experience preparing and supporting regulatory submissions such as 510(k), Pre-IDE, EU Technical Files, STED documentation, or equivalent.
- Strong knowledge of medical device regulations, including FDA 21 CFR 820, ISO 13485, ISO 14971, and related global standards.
- Experience in product lifecycle support, including design control, validation, and commercialization processes.
- Strong understanding of risk management principles and quality system requirements in regulated industries.
- Excellent written and verbal communication skills with the ability to interact across technical and non-technical teams.
- Strong organizational skills with the ability to manage multiple priorities and meet strict deadlines in a fast-paced environment.
- Detail-oriented mindset with strong documentation, analytical, and problem-solving abilities.
- Ability to collaborate effectively across cross-functional and international teams and present information clearly when needed.
Responsibilities
- Support regulatory and quality activities across the product lifecycle, including design control, verification and validation, design transfer, and product modifications.
- Contribute to the preparation, drafting, and review of regulatory submissions for U.S. and international markets, including 510(k), Pre-IDE, EU Technical Files, and related documentation.
- Review and evaluate technical protocols, clinical data, and validation/verification documentation to ensure regulatory compliance.
- Provide regulatory input into risk management activities and lifecycle management processes in alignment with applicable standards.
- Support labeling and instructional material development, ensuring compliance with FDA, ISO, and international regulatory requirements.
- Assess regulatory impact of product design changes and change control activities, ensuring appropriate documentation and compliance actions.
- Support adverse event reporting, medical device reporting (MDR), and product recall or correction/removal activities.
- Collaborate with Sales, Marketing, and cross-functional teams to ensure promotional and technical content meets regulatory requirements.
- Assist in audit preparation and participate in internal and supplier quality audit activities as needed.
- Contribute to long-term regulatory and quality initiatives supporting organizational goals and product expansion strategies.
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