Overview

Represents the Regulatory Affairs function in assigned project teams and completes projects and tasks to established timelines to meet corporate objectives. Ensures compliance with state, federal and International medical device regulations and overall regulatory department objectives. Negotiates the content and structure of regulatory filings with international partners, agents, and distributors. Develops, prepares, and maintains US and international regulatory filings and documentation and interacts with regulatory authorities to achieve timely approvals.

Responsibilities

• Supports RA department in assigned project meetings and provide regulatory guidance to ensure adherence with global regulatory requirements as appropriate.
• In collaboration with Regulatory Management, project teams, and/or international partners, evaluates possible pathways to marketing authorization and recommends strategy and pathway that appropriately weighs the probability of success with potential risks to the business. Executes these sound regulatory strategies to support business goals.
• Reviews and approves document change orders (DCOs), manufacturing nonconformance documents, CAPA plans and reports, technical documents, test protocols and reports, risk management documents, labeling documents, and other documents as a key member of assigned project teams.
• Assesses product and manufacturing changes and develops regulatory assessments for each global market as to impact upon current approvals. Prepares well-justified Letters to File (LTFs) for those deemed to meet the threshold for not requiring prior approval.
• Negotiates with international staff, agents and distributors on technical data and submission filing contents. Interacts with international representatives in a respectful, professional manner to ensure regulatory submission projects remain on track and issues or queries are identified and resolved in conjunction with project teams as expediently as possible.
• Develops, prepares, and submits high quality technical information for submission in geographies. Establishes timelines, manages sub-team meetings relevant to the regulatory processes, and ensures timely execution.
• Under the direction of Regulatory Affairs management, executes regulatory aspects for any field corrective actions in a timely, thorough, and transparent manner. Develops reports for submission to global regulatory authorities and responds to requests for information.
• Maintains up-to-date knowledge on domestic and international regulatory requirements, and effectively communicates requirements to project teams and management.
• Updates departmental procedures as required
• Perform other duties as assigned by Regulatory Affairs Management

Qualifications

• Good interpersonal skills including ability to interact with high degree of diplomacy
• Extensive knowledge of medical device regulations
• Comprehensive knowledge of quality systems and relationship to business
• Complete understanding and wide application of technical or regulatory principles, theories and concepts. General knowledge of other related disciplines
• Ability to facilitate and provide input when interpreting regulatory standards and guidance documents
• Ability to work in a fast-paced, technically challenging environment where drive is critical to success
• Must be self-motivated, self-disciplined, and able to prioritize and handle multiple tasks and responsibilities within internal and external commitment dates
• Effective problem-solving skills
• Excellent applied thinking skills and technical writing skills
• Strong communication, and organization skills required
• Expertise in Microsoft Office applications and charting programs
• Product development team experience
• Experience in developing and communicating global regulatory strategies