About the job

This individual will join our client's regulatory team and collaborate with other departments like R&D, Manufacturing, Quality Assurance, and Commercial. Here's what you'll be responsible for:

• Preparing Regulatory Submissions: You'll draft submissions for international markets and the FDA, including Technical Documents, Files, Device Applications/Amendments, and PMAs.
• Data Gathering and Support: Identify and collect data needed for filings, responses to inquiries, and registration maintenance. This ensures products meet global regulatory requirements for commercialization.
• Clinical Evaluation Reports: You'll be responsible for creating and updating annual Clinical Evaluation Reports, including State of the Art and Subject Literature Reviews.
• Regulatory Submissions Expertise: As a key contributor, you'll prepare and review submissions following US and international regulatory requirements. You'll also ensure complete and timely responses to Health Authorities during application review.
• Subject Matter Expert: Serve as a resource on regulatory affairs, providing training and guidance to team members as needed.
• Regulatory Procedures: Author and/or review regulatory procedures and update them when necessary.
• Regulatory Knowledge: Possess a strong understanding of medical device regulations, including FDA regulations (e.g., 21 CFR Part 820, 21 CFR Part 11), ISO standards (e.g., ISO 13485, ISO 14971), and international regulatory frameworks.
• Communication and Collaboration: Demonstrate excellent communication skills and collaborate effectively with cross-functional teams.
• Project Team Participation: Actively participate in cross-functional project teams as a global regulatory advisor.
• Technical Documentation Review: Review technical documentation to ensure it supports regulatory applications.
• Competitive and Technical Awareness: Maintain a strong understanding of competitive technologies and medical/technical developments relevant to our client's products.

What You Bring to the Table:

• Proven Regulatory Experience: This role requires strong experience with pre-market regulatory activities in the US, EU, and other global markets.
• Success with Regulatory Agencies: You have a proven track record of successful regulatory submissions and interactions with regulatory agencies (FDA, Notified Bodies, etc.).
• Fast-Paced Environment: You thrive in a dynamic and fast-paced work environment.
• Integrity and Character: You possess high integrity, character, and are a person who is tough-minded, fair, and principled.
• Creative Problem-Solving: You have strong analytical and problem-solving skills with the ability to develop innovative solutions.
• Project Management Skills: You can prioritize tasks, manage multiple projects, and set/manage timelines with urgency.
• Communication and Interpersonal Skills: You are self-confident, decisive, and possess excellent communication skills in both written and oral formats. Additionally, you are a great listener, presenter, and problem solver.
• Teamwork and Collaboration: You can interface effectively at all levels and functions within the organization.

Supervisory Responsibilities:

• Manage internal and external resources.

Education and Experience:

• 7-10 years of experience in regulatory affairs within the medical device industry, with a preference for implantable devices.
• Bachelor's or master's degree.
• A "hands-on" style that fosters a strong, cohesive, team-focused work environment.
• Technical and continuous improvement experience with emphasis on managing and deploying continuous product development for medical devices.
• A proven track record in therapy innovation, technology implementation, and commercialization.
• A demonstrable track record of achieving and maintaining high-quality standards.
• Complete training as outlined in the company's training plan, including mandatory training on Insider Trading, Anti-Bribery/Corruption Policies, and Code of Business Conduct and Ethics.