Especialista Senior de Asuntos Regulatorios

QRA is responsible for developing and implementing quality and regulatory policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.

Job Responsibilities

This position is responsible for, but not limited to, the following:

  • Provide input for regulatory requirements and regulatory strategies on product development to ensure timely submission and approval.
  • Compile and review all regulatory agency submission materials to ensure timeliness, accuracy, completeness, and compliance with regulatory standards.
  • Integrates and demonstrates core values, integrity and accountability.
  • Conveys or exchanges information with internal and external stakeholders.
  • Directs and contributes to initiatives within the organization, with groups engaged in developing good regulatory practice and policy, and within the regulatory profession.
  • Provides clarity and direction amid complexity and develops solutions for self, colleagues and the organization.
  • Applies knowledge of regulatory frameworks/solutions and external environments throughout the product lifecycle.
  • Leverages systems and processes to successfully operate a regulatory function.
  • Demonstrates knowledge of requirements and processes to maintain product on the market, including reporting and surveillance.
  • Presents registration documents to regulatory agencies and carries out all the subsequent negotiations necessary to obtain and maintain marketing authorization for products/devices.
  • Provides strategic and technical advice throughout product life-cycle, making an important contribution both commercially and scientifically to the success of a development program.
  • Other duties as assigned.

Required Knowledge and Skills:

  • Experience in analyzing and developing strategies for regulatory submissions and compliance issues including, but not limited to successful development and implementation of regulatory strategy for Class II or Class III medical devices resulting in global regulatory product approvals, strongly preferred.
  • Experience with medical device product development; regulatory manufacturing device registrations, quality system, new product development, design controls.
  • Working knowledge of International Device regulations with specific experience with Medical Device regulatory submissions.
  • Experience managing, developing, organizing, and maintaining regulatory files.
  • Demonstrated track record of successful regulatory submissions. Strong organizational and interpersonal skills.
  • Able to manage multiple projects with shifting priorities and work independently with limited supervision.
  • Manage complex problems/projects by exercising independent decision making and analytical thinking skills, with limited supervision.

Required Qualifications    

  • Bachelors degree in Life Sciences (Pharmacology preferred) or similar field
  • 3-5 years of experience in Global Regulatory Affairs, preferably with a global manufacturer of medical devices or within a highly regulated industry
  • Advance proficiency in Spanish and English is a must.
  • Demonstrated expertise in regulatory and quality concepts, practices and procedures.

Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.