Sr. Regulatory Affairs Specialist - REMOTE

About the position This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Principal Regulatory Affairs Specialist. In this role, you will support the development and implementation of long-range regulatory strategies that impact the introduction of new products and the compliance of existing ones. Your leadership will guide regulatory staff, ensuring all products meet U.S. and international standards. You will be a key player in compliance activities and bear significant responsibility in product development and modifications.

Responsibilities

• Maintain current knowledge of applicable laws and regulations.
• Interpret regulatory requirements for products and ensure compliance.
• Participate as a regulatory representative on project teams.
• Lead submission activities for device clearances/approvals.
• Review change orders and assess regulatory impact.
• Oversee labeling, training, and promotional material compliance.
• Represent the organization in working groups related to regulatory objectives.
• Support due diligence and post-acquisition assessments.
• Develop and implement regulatory education and training.
• Assist in policy and procedure development within the department.

Requirements

• Bachelor’s Degree with 7+ years in regulatory affairs or relevant field.
• Medical device experience is required.
• Experience with 510(k) or PMA submissions for FDA.
• Knowledge of U.S. and EU regulations for medical devices.
• Excellent communication and presentation skills.
• Ability to manage multiple projects with attention to detail.
• Proficiency in MS Word, Excel, and PowerPoint.

Benefits

• Competitive salary and flexible benefits package.
• Health, Dental, and Vision insurance.
• 401(k) plan with employer match.
• Paid time off and holidays.
• Tuition assistance and reimbursement.
• Employee Stock Purchase Plan.
• Short-term disability and life insurance.
• Employee Assistance Program.

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