Regulatory Affairs Leader

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

📋 Description

• Provides regulatory leadership and strategic guidance for ARC's regulatory initiatives.

• Aids in global registration planning, submissions, notified body and quality system audits, and implementation of programs across various cross-functional teams.

• Engages with leadership and collaborates with healthcare regulatory authorities worldwide.

• Formulates regulatory strategies to enhance submission pathways, taking into account testing, clinical data, product claims, and country-specific requirements.

• Clearly articulates information, evaluates risks, devises solutions, and fosters consensus.

• Identifies situations where senior Regulatory Affairs support is necessary.

• Employs technical knowledge, judgment, and analytical skills to address challenges.

• Evaluates product modifications and assesses the necessity for new or updated licenses or registrations.

• Reviews and endorses advertising and promotional materials to ensure compliance with claims and regulations.

• Assists in drafting and refining technical documentation.

• Conducts research, analyzes, integrates, and organizes information for regulatory submissions.

• Implements regulatory requirements for both pre-market and post-market compliance.

⛳️ Requirements

• Advanced experience in Quality & Regulatory Affairs; knowledge level equivalent to a Bachelor's degree from an accredited university or college.

• At least 3 years of experience in a regulated environment.

• Exceptional communication skills in English, both written and verbal.

• Strong project management, communication, and organizational abilities.

• Capability to work autonomously in a dynamic environment and adapt to changes effectively.

• Proficient in prioritizing information for data analysis and recognizing when additional information and support are required.

• Team-oriented and responsive to customer demands.

• Meticulous attention to detail and a results-driven mindset.

• Ability to comprehend technical documentation and implement related procedures.

• Legally authorized to work in the United States.

• Successful completion of a drug screening, if applicable.

🏝️ Benefits

• Opportunities for professional development.

• Engaging and challenging career paths.

• Competitive salary and compensation packages.

• Positive and supportive work environment.

• Opportunities for career advancement.

• A culture that promotes care, collaboration, and support.