Senior Regulatory Affairs Specialist

This is a fully remote position, open to applicants in Texas.

📋 Description

• Oversee a regulatory affairs team primarily focused on the Restorative Healing Technologies portfolio.

• Facilitate both early- and late-stage product development through essential milestones and regulatory activities that lead to global product approvals.

• Ensure ongoing product compliance throughout the entire device lifecycle.

• Foster strong relationships with stakeholders, management, and contract organizations.

• Cultivate a team with the skills and expertise necessary to support the business's strategic objectives.

• Create and implement regulatory strategies for new product market authorizations, indications, and claims.

• Navigate complex regulatory decision-making among cross-functional stakeholders.

• Represent Regulatory Affairs in global business and functional strategic meetings and forums.

• Conduct regulatory assessments and outline registration plans in conjunction with the business.

• Clearly communicate global registration requirements and assemble regulatory documents in line with local requirements.

• Submit registration documents and monitor evaluations until regulatory authorization is achieved.

• Serve as the primary contact for commercial support related to regulatory activities.

• Oversee regulatory systems and tools, data tracking, and maintain regulatory data integrity.

• Evaluate advertising and promotional materials to ensure alignment with approved claims.

• Keep abreast of new regulations and provide regulatory information, updates, and documentation.

• Assist with ISO 13485, MDSAP, and Technical Surveillance audits.

• Perform additional duties, responsibilities, or assigned projects as needed.

⛳️ Requirements

• Bachelor's Degree or higher (completed and verified before starting) AND seven (7) years of Regulatory Affairs experience within a regulated industry in a private, public, government, or military setting OR High School Diploma/GED (completed and verified before starting) AND eleven (11) years of Regulatory Affairs experience within a regulated industry in a private, public, government, or military setting.

• Master's Degree or higher in a scientific, engineering, regulatory, or quality discipline.

• Three (3) years of experience in preparing and/or supporting regulatory submissions, including 510(k) submissions, EU MDR submissions, or other international medical device regulatory submissions.

• Three (3) years of experience assisting with ISO 13485 and/or MDSAP audits.

• Experience in supporting regulatory activities for negative pressure wound therapy devices and/or wound care medical devices.

• Experience in supporting regulatory activities for absorbable wound care dressings and matrices.

• Experience in supporting regulatory activities for electro-mechanical devices and/or embedded or stand-alone software medical devices.

• Must be legally authorized to work in the country of employment without sponsorship for employment visa status.

🏝️ Benefits

• Medical, Dental & Vision.

• Health Savings Accounts.

• Health Care & Dependent Care Flexible Spending Accounts.

• Disability Benefits.

• Life Insurance.

• Voluntary Benefits.

• Paid Absences.

• Retirement Benefits.

• Up to 10% domestic/international travel opportunity.