Acelity Careers

Director, Regulatory Affiars

San Antonio, United States of America
Science and Engineering


Job Description

Job Summary:

The Director, Regulatory Affairs is an essential team member of the Business Unit Franchise.  And  establishes the Global Regulatory Strategy for the business unit’s product platforms and new products.  This position works closely with the business unit franchise to create and deliver on regulatory strategies that enable the goals of the business to be met while assuring compliance to regulations. This position also works with the sustaining engineering functions to support post market changes to product platforms.

Principle Responsibilities: (essential job duties and responsibilities)

  • Provides regulatory support and guidance to assigned business franchise to enable the timely commercialization of new products and product updates. 
  • Architects the overarching regulatory strategies for the franchise’s product platforms.  Develops a regulatory strategy for each new product development project to facilitate timely commercialization and globalization.
  • Interprets regulations to develop solutions to regulatory challenges in order to satisfy business needs while ensuring compliance to regulations.
  • Collaborates closely with global Regulatory Affairs subject matter experts to establish regulatory plans for OUS countries included in the launch plans for new products.
  • Prepares regulatory submissions to obtain clearance by the FDA.  Develops requirements for content of technical protocols, reports, and summaries used in support of the submissions.
  • Provides guidance and advice to new product development teams on design development to ensure project activities are in alignment with the planned regulatory strategy.
  • Reviews and approves product labeling.
  • Works with the Regulatory Affairs Project Management to create project schedules to plan the execution and timing of regulatory activities.
  • Reviews and approves promotional and advertising materials as well as medical education training, literature, and copy materials to assure compliance with cleared/approved labeling and marketing requirements.  Recommends alternate language, as appropriate, to ensure acceptable regulatory alternatives.
  • Assesses design, labeling, and manufacturing changes to products and determines impact to regulatory filings.  Advises project teams on regulatory approach for changes and prepares submissions or letter to file documentation as required.
  • Acts as a liaison between the business unit franchise new product development teams and the OUS Regulatory Affairs team.
  • Maintains current knowledge of FDA and international regulations, guidances and standards applicable to company products.

Skills and Experiences:

  • Proficiency with Microsoft Office business software.
  •  Ability to develop and maintain effective working relationships with employees and external business contacts.
  • Ability to communicate effectively, orally and written.
  • Ability to maintain confidentiality and discretion in business relationships.
  • Ability to create technical documentation that can be easily understood by regulatory agencies.

Education:

  • Bachelors Degree in a technical or scientific field to include Life Sciences, Engineering Sciences, or similar disciplines or equivalent experience.
  • Masters Degree in a technical or scientific discipline, preferred.

Minimum Qualifications:

  • Ten(10) years experience working in the medical device industry.
  • Five (5) years experience in global Regulatory Affairs for medical devices.
  • Experience working with new product development teams, and substantial knowledge of Design Controls.
  • Experience analyzing technical and scientific data and reports.
  • Experience reviewing promotional and advertising materials.

Preferred Qualifications:

  • Knowledge of and experience with FDA.
    • Knowledge of  enterprise application integration techniques.
    • Apex programming
    • Knowledge of  enterprise application integration techniques.
    • Apex programming
  • Experience with electromechanical devices containing software.
  • Experience with FDA software verification and validation requirements.
  • Knowledge of global medical device regulations and standards
  • Experience working in International Regulatory Affairs for medical devices.
  • Regulatory Affairs Certification (RAC)

KCI is an Equal Employment Opportunity/Affirmative Action, Federal Contractor employer. All qualified applicants are encouraged to apply and will be considered without regard to race, sex, color, religion, national origin, age, genetic information, disability, protected veteran, or other legal protected

The information listed above is not a comprehensive list of all duties/responsibilities performed. This job description is not an employment agreement or contract. Management has the exclusive right to alter this job description at any time without notice. Any physical and mental requirements described in this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. EOE AA M/F/Vet/Disability: Acelity L.P. Inc. and its subsidiaries are an equal opportunity and affirmative action employer and give consideration for employment to qualified applicants without regard to race, ethnicity, color, religion, sex, sexual orientation, gender identity, pregnancy, national origin, age, disability, veteran status, or genetic information or any other legally protected characteristic. If you'd like more information about your EEO rights as an applicant under the law, please click here: http://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf VEVRAA Federal Contractor