Director of Regulatory Affairs

Description

Aim (Why does the role exist?): To build and execute a regulatory strategy that delivers approvals of IMMY’s in vitro diagnostic products through Global Regulatory Authorities, primarily US FDA 510(k), IVDR, ANVISA, CDSCO, and others. Also, to lead and develop a Regulatory Affairs team who can effectively and efficiently ensure the availability of IMMY’s product solutions throughout the world in alignment with IMMY’s vision and goals. This role also ensures that IMMY’s products meet all safety, quality, and regulatory standards while driving efficiency and compliance throughout the product lifecycle.

Goal (What does success in the role look like?): To execute compelling regulatory submissions to Regulatory Authorities and deliver successful approvals for IMMY’s in vitro diagnostic solutions. This is accomplished through building, developing, and leading a team that greater impact both individually and for IMMY.

Key Duties And Responsibilities

LMA

Leading

• Setting Vision and Direction: Leaders play a crucial role in translating IMMY's vision into actionable strategies for their teams. They communicate broader objectives and goals, ensuring team members understand and are aligned with the organizational vision.
• Motivating and Inspiring: Effective managers inspire and motivate their teams, fostering a positive work environment. They encourage professional growth, set clear expectations, and lead by example to achieve the desired results and champions and exemplifies IMMY’s Core Values.
  
  

Managing

• Planning and Organizing: Managers are responsible for organizing and planning team projects. This involves guiding the team to break down larger goals into achievable tasks, setting timelines, and allocating resources effectively for the team.
• Delegating and Supervising: Managers delegate responsibilities among team members according to their strengths and skills. They oversee the progress, provide guidance, and ensure that the team’s responsibilities and projects are completed efficiently.
  
  

Accountability

• Setting Expectations: Managers establish clear expectations for their team members. They communicate what needs to be accomplished, outlining roles, responsibilities, and performance standards.
• Monitoring Progress and Performance: Holding individuals accountable involves regular monitoring of progress and performance. Managers track performance against objectives, provide feedback, and address any issues that may hinder success.
• Recognition and Feedback: Effective managers provide constructive feedback and recognition for good performance. They acknowledge achievements, support professional development, and address any underperformance through coaching or corrective actions.
  
  

Own the Development & Execution of Regulatory Strategy

• Collaborate in crafting and executing a global regulatory strategy in line with IMMY’s vision and goals.
• Align product registrations with IMMY’s vision, the product development roadmap, and market demands.
• Effectively communicate internally and externally relevant regulations, procedures, and policies to all employees and stakeholders as necessary
  
  

Develop Systems for Efficient & Effective Global Regulatory Approvals

• Standardize regulatory operations and establish clear, documented procedures
• Interact with regulatory bodies to ensure completion of product registrations
• Maintain a deep understanding of new and existing regulations that may impact IMMY’s products and processes
• Maintain knowledge of submission requirements and processes for multiple regulatory jurisdictions
  
  

Support Execution of Regulatory Affairs Deliverables in the Develop Process

• Manage the preparation, coordination, and compilation of all technical documentation
• Ensure Pivotal Clinical Study Designs Fulfill Regulatory Submission Needs
• Assist in the development of Verification & Validation Studies
• Assist with Clinical Study Design
• Ensure labeling, promotional, legal, and technical documentation is compliant
  
  

Act as Person Responsible for Regulatory Compliance

• Ensure labeling, promotional, legal, and technical documentation is compliant Maintaining technical documentation throughout the product life cycle
• Ensure system for shipping restriction compliance is in place and effective
  
  

Qualifications

Qualifications include:

• Bachelor’s degree in science or combination of other education/job related experience
• 5+ years of managerial experience (including staffing, pay decisions, training, evaluation, supervision, budgeting, and policies)
• Experience with writing US FDA 510(k) IVD regulatory submissions, including Q-Submissions or Pre-Submissions
• Experience in an IVD or Medical Device regulated environment
• Familiarity with FDA, IVDD, IVDR, ISO 13485, GMP and other major international regulatory requirements
• Ability to read and interpret IVD domestic and international regulations
• Effective technical writing and oral communication skills
• Extremely organized with high attention to detail
• Effective at multi-tasking
• Ability to work in a fast-paced, timeline-driven environment
• Ability to work independently and as part of a team
• Ability to organize information so that it is easily understood and reviewed, both internally and externally
• Ability to identify ways to improve/simplify processes
  
  

Equal Opportunity Employment: IMMY is committed to the principle of equal employment opportunity for all employees and applicants for employment and prohibits discrimination and harassment of any kind without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, and local laws. IMMY will not tolerate discrimination or harassment based on any of these characteristics. This policy applies to all terms and conditions of employment, including, but not limited to, recruiting, hiring, promotion, termination, leaves of absence, compensation, and training.

Background Check Policy: All offers of employment at IMMY are contingent upon clear, acceptable results of a thorough background check. IMMY performs all background checks in compliance with EEOC and FCRA regulations and all other applicable federal, state, and local laws.