Especialista Sr de Asuntos Regulatorios

**_What Regulatory Affairs contributes to Cardinal Health_**

**_ Accountabilities in this role_**
- Prepare, assemble and submit regulatory submissions, dossiers and other Cofepris regulatory submissions.
- Provide input for regulatory requirements and regulatory strategies in interdepartmental meetings on product development to ensure timely submissions and approval.
- Liaise with external and internal stakeholders to ensure proper documentation, specifications and standards are gathered to guarantee successful submissions.
- Determine product classifications, regulatory filing strategies and submission types. Participate in medical device product development teams and develop overall regulatory strategy that delivers on project costs, timeline and regulatory bodies approval (ANVISA)
- Responsible for performing all duties in compliance with ISO13485, EU Directives, FDA’s Quality Systems Regulations and GMP's; and other applicable international regulatory requirements.
- Responsible for regulatory related design and development activities, including providing input on materials, testing, validations, and other outputs to demonstrate compliance with regulatory requirements.
- Maintain regulatory affairs documents and systems including the Regulatory Product Submissions and Regulatory Tracking database.
- Provide input on and review of protocols and reports for: design verification and validation for material, process and facilities changes, assay/method validation, shelf life, clinical and non-clinical studies, material qualification and safety testing in support of product submissions and marketing collateral.
- Determine governmental regulations affecting Company processes and assure the processes are complete and accurate to ensure company compliance. Formulate and proposes regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
- Review technical publications, articles, and abstracts to stay abreast of regulatory and technical developments in the industry.
- Adhere to the Company's quality system including but not limited to the applicable standards, policies and procedures in the areas of responsibility defined in this job description.
- Perform other duties as assigned..

**_ Qualifications_**
- Bachelor’s Degree in a scientific discipline and/or a related field.
- Advance proficiency in English & Spanish
- 3+ years of experience in Regulatory Affairs for medical devices
- Proven experience with preparation of regulatory submissions and demonstrated track record of successful regulatory approvals for medical devices
- Demonstrated track record of successful negotiations with Cofepris with respect to product submissions and regulatory strategies
- Knowledge of FDA's Quality Systems Regulations, GMP's, ISO13485
- Expertise in technical and operational aspects of regulatory affairs

**_
What is expected of you and others at this level_**
- Works on projects of moderate scope and complexity
- Identifies possible solutions to a variety of technical problems and takes action to resolve
- Applies judgment within defined parameters
- Receives general guidance and may receive more detailed instruction on new projects
- Work reviewed for sound reasoning and accuracy
- Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. 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._