Sr. Regulatory Affairs Specialist - Recall and Post-Market Compliance (Hybird/Remote)
About The Position
The Senior Regulatory Affairs Specialist will be an instrumental member of the Regulatory Affairs team supporting on-market in vitro diagnostic (IVD) products in the United States and international markets. This role is responsible for supporting post-market regulatory compliance activities, including adverse event reporting, field actions, recalls, post-market surveillance, and regulatory assessments. The individual will serve as a key regulatory partner to cross-functional teams, providing guidance on regulatory requirements, risk evaluations, and reporting obligations. The role will also contribute to continuous improvement initiatives through the development and implementation of regulatory procedures, work instructions, and best practices that strengthen post-market compliance and regulatory oversight.
Requirements
- Typically requires a minimum of 5 years of related experience with a Bachelor’s degree; or 3 years and a Master’s degree; or a PhD without experience; or equivalent work experience
- Strong understanding of FDA regulations required
- Demonstrated ability to work independently with new, complex technologies and produce professional work products
- Strong written and verbal communication skills
- Familiarity and ability to work with office automation programs and corporate database tools
- Strong work ethic and demonstrated ability to deliver assignments on time
Nice To Haves
- 5+ years experience in Regulatory Affairs
- Experience with an in vitro diagnostics device company preferred; pharmaceutical, biologics or medical device companies as alternative
- other international requirements - EU, Canada, Australia, Japan and China - preferred
- Team leadership skills preferred
Responsibilities
- Represents the RA function on assigned cross-functional project teams
- Interprets and applies regulations by creating regulatory strategies for domestic and international markets
- Develops and executes regulatory plans for complex projects including new products and maintenance of approvals/licenses/authorizations for existing marketing authorizations
- Prepares hardcopy and electronic information packages for submission to regulatory agencies
- Provides recommendations on labeling, manufacturing, and analytical and clinical study plans for regulatory compliance
- Reviews validation, clinical and stability protocols and reports for regulatory submission soundness
- Assesses manufacturing process and labeling through change control for regulatory reporting impact and compliance to regulations
- Defines, monitors and receives deliverables for submissions
- Writes and/or edits submission documents using regulatory templates, or creates new templates
- Assembles paper and/or electronic copies for submission
- Monitors new and revised regulatory requirements; disseminates information as directed by management
- Interacts with regulatory agencies and third party accrediting bodies
- Prepares internal procedures for continuous process improvement
- Provides regulatory guidance and/or training to external departments and partners
Benefits
- access to genomics sequencing
- family planning
- health/dental/vision
- retirement benefits
- paid time off
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
