Senior Regulatory Affairs Specialist - Remote

Overview

The Senior Regulatory Affairs Specialist represents the Regulatory Affairs department in project teams, providing regulatory input to meet corporate objectives and ensuring compliance with medical device regulations.

In Short

• Represents Regulatory Affairs in project meetings.
• Develops regulatory strategies for marketing authorization.
• Assesses product and manufacturing changes for compliance.
• Reviews and approves technical documents and promotional material.
• Interacts with regulatory bodies professionally.
• Prepares and submits technical documentation for approval.
• Represents the department in audits and assessments.
• Maintains up-to-date knowledge on regulatory requirements.
• Updates departmental procedures as necessary.
• Other duties as assigned.

Requirements

• Bachelor's degree in a scientific or technical discipline.
• Minimum 4 years of Regulatory Affairs experience.
• Experience with Class III medical devices is preferred.
• Strong knowledge of US and international regulations.
• Ability to interpret regulatory requirements.
• Excellent communication and interpersonal skills.
• Strong problem-solving abilities.
• Ability to manage multiple assignments effectively.
• Ability to work independently and collaboratively.
• Willingness to travel as required.

Benefits

• Medical, dental, and vision insurance.
• 401(k) matching plan.
• Paid Time Off starting at 3 weeks per year.
• Competitive salary with growth opportunities.
• Employee stock options.
• Life & AD&D and long-term disability insurance.
• Education assistance.
• Voluntary commuter benefits and pet insurance.
• Meaningful work and much more!