Staff Regulatory Affairs Specialist

This is a fully remote position, open to applicants in Alabama, +33 more states.

📋 Description

• Oversee, prepare, and finalize premarket applications for the US FDA, which includes 510(k), Pre-Sub, and De Novo submissions.

• Serve as the primary contact with the FDA concerning product submissions.

• Evaluate if proposed modifications to devices necessitate a 510(k) application.

• Draft non-filing justifications for changes that do not need a 510(k) submission.

• Organize and compile technical files for European Notified Bodies for CE marking of new and updated products.

• Provide regulatory leadership and direction to multidisciplinary product development teams.

• Identify and articulate quantified regulatory risks along with mitigation strategies.

• Manage Notification of Change and International Regulatory Affairs evaluations for ongoing activities.

• Formulate regulatory strategies for Change Controls and establish Regulatory Requirements.

• Assist global regulatory strategies and collaborate with international regulatory team members.

• Spearhead regulatory initiatives for new regulations and international standards, including EU MDR/IVDR and MDSAP.

• Review and authorize product labeling, promotional content, and advertising materials.

• Coordinate replies to customer inquiries regarding product information and questionnaires.

• Maintain FDA device listings and facility registrations.

• Create and uphold SOPs, work instructions, and organizational policies.

• Represent BD in external trade organizations and support the development and compliance of regulatory standards.

• Enhance the effectiveness of existing work processes.

⛳️ Requirements

• A B.S. degree in a scientific, health sciences, or technical field is required (e.g., engineering, bioengineering, biology, chemistry).

• A minimum of 5 years of experience in Regulatory Affairs within the medical device or in vitro diagnostic device sectors.

• Strong technical writing abilities and experience compiling successful submissions tailored to the intended audience.

• Proven experience in maintaining confidentiality while managing regulatory and clinical documentation.

• Experience in cross-functional collaboration and teamwork, including the ability to influence without direct authority.

• Proficiency in Microsoft Word, Excel, and PowerPoint.

🏝️ Benefits

• Medical, dental, vision, health savings, and flexible spending accounts.

• Life and disability insurance.

• Wellness resources.

• Mental health support and disease management programs.

• 401(k) plan.

• Deferred compensation options.

• Financial counseling services.

• DailyPay option.

• Educational savings plans.

• Paid time off.

• Company holidays.

• Educational assistance programs.

• Parental leave.

• Adoption assistance.

• Backup care services.

• Caregiving support.

• Employee assistance programs.

• Commuter benefits.

• Pet insurance.

• Legal services.

• Associate discount programs.

• Leave for bereavement, military service, personal matters, family and medical needs, and jury duty.

• Opportunities for recognition and rewards.

• Competitive salary and comprehensive benefits packages.