Principal Regulatory Affairs Strategy Associate

About the role

The Principal Regulatory Affairs Strategy Associate will support regulatory strategy and compliance activities for ophthalmic products. This role partners with cross-functional teams to drive regulatory submissions, product approvals, lifecycle management, and compliance initiatives.

Responsibilities

• Lead regulatory strategy and support for new and existing ophthalmic products.
• Manage regulatory submissions, renewals, registrations, and product changes.
• Collaborate with internal teams, regulatory agencies, and external partners to ensure timely approvals.
• Provide regulatory guidance for product development, commercialization, and lifecycle management.
• Review and support promotional materials to ensure regulatory compliance.
• Drive multiple regulatory projects and support business development and integration activities.
• Ensure compliance with applicable regulations, quality standards, and SOPs.

Requirements

• Bachelor's degree and 7+ years of Regulatory Affairs experience (or equivalent combination of education and experience).
• 5+ years of leadership or project leadership experience.
• Experience supporting medical devices, pharmaceuticals, or combination products.
• Strong knowledge of regulatory submissions, compliance requirements, and product registration processes.
• Excellent communication, project management, and problem-solving skills.

Qualifications

• Master's degree in a relevant field (e.g., Biomedical Engineering, Pharmaceutical Sciences, etc.) preferred.
• Experience in a global regulatory environment.
• Knowledge of FDA, EMA, and other international regulatory bodies.
• Experience with regulatory frameworks and guidelines for medical devices and pharmaceuticals.

Skills

• Strong understanding of regulatory submission processes and compliance requirements.
• Experience with regulatory strategies and compliance initiatives.
• Excellent written and verbal communication skills.
• Project management and organizational skills.
• Ability to work independently and collaboratively in a team setting.

Benefits

• Medical
• Dental
• Holiday
• PTO
• 401K matching

Pay

Low: $80.00 | High: $83.00

Schedule

8-Month Contract (Potential Extension)