Director, Regulatory Affairs – International

Job content

Summary Of Major Responsibilities

Director, Regulatory Affairs (RA) International is responsible for managing international registration, tender and import related regulatory activities, and supporting new and existing product lines. This leadership role will interpret and provide international regulatory requirements to product teams and ensure that corporate processes are compliant, current, and efficient. This role will work cross-functionally to coordinate with U.S. based Regulatory, Product Development, Operations, and business unit leadership to assure product registrations and compliance across multiple markets. The Director, Regulatory Affairs International may recruit, develop, mentor, and lead regulatory professionals.

This position is located in Zug, Switzerland.

Essential Duties And Responsibilities

• Establish international registration processes for in vitro diagnostic (IVD) products and complete international registration and tender and import related regulatory activities per plan with minimal supervision.
• Support product teams and the International Business Unit by defining international regulatory requirements, drafting dossier and technical files, guiding processes development and maintenance to assure adherence to In Vitro Diagnostic Regulation (IVDR) and other international and national standards, as appropriate.
• Provide support to regulatory inspections, such as International Organization for Standardization (ISO) and Food and Drug Administration (FDA) audits.
• Identify and develop new regulatory policies, processes, and Standard Operating Procedures (SOPs).
• Serve as a principal interface with reviewers and auditors from national and regional health authorities (e.g., Notified Bodies, National/Regional competent authorities, etc.).
• Provide regulatory advice to other functional areas.
• Identify perceived gaps in product development plans that may pose regulatory issues.
• May lead cross-functional or cross-business teams to address process improvements, major international regulatory changes, or initiatives.
• Develop and maintain relationships with external vendors and regulatory authorities to improve effectiveness in regulatory strategy execution.
• Oversee regulatory authority inspections and provide input for follow-up to inspections and audits to minimize potential for findings of noncompliance.
• Oversee activities related to post-market surveillance.
• Oversee activities related to product recall and recall communication process.
• Assure medical device reports (MDR) are reported to regulatory agencies and internal stakeholders.
• Manage processes involved with maintaining annual licenses, registrations, and listings.
• Ensure compliance with product post-marketing approval requirements.
• Review product labeling, advertising, and promotional materials.
• Update department personnel, departments, and business units on the current regulatory environment, new regulations, and enforcement actions, as relevant to the business.
• Work with cross-functional leadership to assure appropriate project prioritization and resource allocation.
• Contribute to the annual regulatory plan and budget per corporate and business unit priorities.
• Lead employees, consultants, and contractors in Regulatory Affairs.
• Optimize employee performance by mentoring and developing employees to sustain resource base for evolving business needs.
• Ability to work effectively across teams, functions, and with outside partners.
• Ability to interpret and stay current with FDA, EU, and other national regulations and guidelines.
• Supervise staff; including, but not limited to, organize and prioritize work, write/conduct performance reviews, train/develop, and manage work performance.
• Communicate goals so employees understand them and their role in achieving them.
• Motivate and inspire employees to do their best work through coaching.
• Maintain morale and support employee engagement initiatives.
• Excellent oral and written communication skills.
• Excellent organizational skills and attention to detail.
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
• Support and comply with the company’s Quality Management System policies and procedures.
• Regular and reliable attendance.
• Ability to lift 10 pounds or less for approximately 5% of a typical working day.
• Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 80% of a typical working day.
• Ability to travel between all corporate site locations (U.S. and International).
• Ability to travel up to 30% of working time away from work location, may include overnight/weekend travel.
  
  

Qualifications

Minimum Qualifications

• Bachelor’s degree in a science or medical related field.
• 10+ years of experience in a regulated industry.
• 7+ years of global regulatory experience in the clinical lab or diagnostics industry.
• 7+ years of international experience.
• 5+ years of direct leadership experience to include leadership and development of employees.
• Professional working knowledge of regulatory aspects of IVDs, Software development, Risk Management, Manufacturing and Controls, and quality assurance.
• Strong understanding of the principles and requirements of promotion, advertising, and labeling.
• Fluent to read, write, and speak in the English language.
• Demonstrated ability to perform the Essential Duties of the position with or without accommodation.
  
  

Preferred Qualifications

• M.S. or Ph.D. in a technical area; M.B.A. or J.D.
• 3+ years of experience in clinical laboratory regulations.
• Fluent to read, write, and speak in an additional language, such as Swiss or German.
  
  

EEO Disclosure

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company’s affirmative action program are available to any applicant or employee for inspection upon request.

Job Summary

• Req No.: 2021-7960
• Category: Quality Assurance & Regulatory Affairs