Description

The Director of Regulatory Affairs is responsible for regulatory strategy development and execution. Collaborate cross-functionally on new product development and strategic initiatives to lead the regulatory activities for global commercialization. The incumbent has the ability to innovate, communicate and execute strategic regulatory plans, drive results independently and solve complex problems to meet business obligations on-time. Creates, evaluates and completes domestic and/or international regulatory tasks related to submissions (US), EU technical file compilation, strategy to drive market growth worldwide. This individual is responsible for obtaining regulatory clearances based on company objectives, attending product development meetings, project meetings; as well as collaborating with cross-functional departments to ensure country-specific requirements are met and integrated throughout the design control and post-product launch activities.

Essential Duties and Responsibilities

• Evaluate proposed and upcoming changes in the global regulatory environment to determine and communicate impact to existing or proposed products as well as overall business impact
• Maintains current knowledge of relevant regulations, including proposed and final rules issued by relevant regulatory authorities that may impact the company
• Creates and implements regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced
• Technical writing of procedures and/or SOPs that link to the international regulatory operations
• Provides regulatory strategy/guidance within the cross-functional team and serves as the expert in regulatory affairs for new product development/sustaining projects
• Responsible for the implementation of regulatory strategies and ensures timely submissions of products (US, EU, and ROW) in compliance with applicable regulations and guidance through coordination and preparation of submission documents for the registration of new products and changes to existing products
• Maintain and update technical files on a regular basis to ensure compliance to applicable IVDD/IVDR regulations and standards
• Review and generate a gap assessment report on new guidance and standards to provide to management and recommend follow up measures.
• Responsible for FDA requests to ensure customs/trade compliance
• Responsible for preparation and compilation of regulatory information requested during government audits/inspections, such as with FDA and Notified Body
• Review and assess product, manufacturing and labeling changes for regulatory reporting impact and compliance to regulations
• Experience identifying, communicating and solving regulatory issues that may arise
• Prepare monthly status reports, Key Performance Indicators (KPI) for Regulatory Affairs Management
• Perform special projects as needed

Qualifications and Minimum Requirements

• Bachelor's Degree in a scientific discipline (Biology, Biochemistry, Microbiology, Chemistry, etc.) or Regulatory Affairs (RA) or Quality Assurance (QA). Advanced degree or RAC certification preferred
• Bachelor's Degree with 12+ years or Master’s Degree with 10+ years or PhD Degree with 8+ years’ experience in regulatory affairs and/or related departments within the In-Vitro Diagnostics (IVD) medical device industry and demonstrated ability to present and articulate requirements and influence teams
• Extensive IVDR 2017/746 Transition experience with QMS Gap Analysis and Summary of Technical Documentation (STED) compilation
• Extensive experience with the preparation/updating Essential Requirement Checklist (ERC), General Safety & Performance Requirements (GSPR)
• Regulatory experience of 510(k) & international registration dossier submissions, and EU technical file compilation in a regulated IVD medical device industry
• Experience implementing and/or maintaining quality management systems in an FDA cGMP or CE/ISO-13485 regulated industry setting
• Experience with the preparation for Instructions For Use (IFU) and Safety Datasheet (SDS) for IVD medical devices
• Experience with the preparation, submissions, and approval for IVD medical devices (Class I & II and/or III)
• Working knowledge, understanding and application of principles concepts and practices of government regulations, and applicable standards (e.g. ISO 13485:2016 and ISO 14971:2012)
• Strong leadership capability and technical/scientific background

Preferred Skills/Abilities

• Strong analytical and organizational skills; ability for detail and precision
• Good general mathematical skills, strategies and concepts including the ability to calculate figures and amounts such as percentages
• Strong interpersonal and presentation skills with the ability to influence others in a positive and effective manner
• Experience with IVD Medical Device Immunoassay Development preferred
• Experience with Design Control (IVD Rapid Test and/or ELISA products) preferred
• Ability to organize and analyze technical data and identify issues or gaps is preferred