Senior Regulatory Affairs Specialist
J
JobgetherMedical devices, diagnostics
Remote position available across the United States.Full-TimeSenior
Salary83,000 - 103,700 USD per year
Apply NowOpens the employer's application page
Job Details
- Experience
- At least 5 years of experience in the medical device, diagnostic, biologic, and/or pharmaceutical industry, preferably within regulatory affairs or a closely related function.
- Required Skills
- Project Management
Requirements
- Bachelor’s degree or equivalent.
- A degree in biological sciences, chemistry, or a related scientific discipline is strongly preferred.
- At least 5 years of experience in the medical device, diagnostic, biologic, and/or pharmaceutical industry.
- Regulatory affairs or closely related experience is preferred.
- Current knowledge of U.S. medical device and IVD regulatory requirements.
- Knowledge of Good Laboratory Practices (GLP) and Quality System Regulations (QSR).
- Familiarity with European medical device and IVD regulatory requirements and applicable European quality system standards.
- Strong written and verbal communication skills for collaboration with stakeholders and external regulatory contacts.
- Strong organizational skills and ability to manage multiple priorities in a regulated, cross-functional environment.
- Project management experience is desirable, particularly coordinating regulatory activities across product development and clinical teams.
Responsibilities
- Interpret and apply U.S. and international regulatory requirements for medical devices and IVD products, and guide product development teams.
- Develop regulatory strategies and assess regulatory risks, options, and pathways for new and modified products.
- Prepare and manage U.S. submissions, including 510(k)s, PMA applications and supplements, PDPs, IDEs, and Pre-Submissions.
- Coordinate information and documentation for international product registrations and licensing activities.
- Interact and negotiate with U.S. regulatory agencies and coordinate responses to requests for additional information or data.
- Review clinical protocols and monitor clinical studies to ensure appropriate data is collected for regulatory submissions.
- Analyze clinical study results against regulatory requirements and recommend courses of action.
- Review product release documentation, labels, labeling, and promotional materials for regulatory compliance.
- Provide regulatory guidance on premarket requirements, exports, labeling, and other applicable matters.
View Full Description & ApplyYou'll be redirected to the employer's site
