Acelity Careers

Senior Regulatory Affairs Specialist

San Antonio, United States of America
Science and Engineering


Job Description

ROLES AND RESPONSIBILITIES

This position includes the following essential roles and responsibilities.  Other duties may be assigned consistent with business priorities.

• Participates in establishing global regulatory strategies and plans that lead to new product submissions in support of global product marketing approvals.

• Develops documentation for submissions for new product or new intended uses for existing products in support of domestic and international product marketing approvals.

• Participates on product development teams to develop global regulatory strategy and determine what regulatory submissions are required to market the product globally.

• Assists in establishing global regulatory strategies and plans to obtain the appropriate regulatory clearances/approvals for existing products in terms of modifications to intended use, design, labeling, materials, and manufacturing processes.

• Assists product design and development teams in developing and documenting appropriate design controls.

• Reviews Engineering Change Notices to assure changes are in compliance with global regulations.

• Assists in implementing manufacturing documentation for new products.

• Maintains open communications with Food and Drug Administration (FDA) and other regulatory agencies.

• Prepares and files US premarket submissions, international medical device registrations and CE mark technical files/design dossiers.

• Interprets and utilizes US and international medical device laws and regulations and provide regulatory advice regarding global laws and regulations.

• Reviews product labeling to assure KCI published literature and labels are compliant with global labeling and marketing regulations.

• Prepares and maintains regulatory files and tracking databases.

• Prepares, revises, reviews, and maintains procedures to harmonize global regulatory policies and processes.

• Provides effective communication to KCI project teams regarding new regulations, policies and initiatives that could impact KCI’s products and processes.

• Assists with preparation for and participate in regulatory agency audits.

• Reviews and approves labeling, product process changes, and product documentation as it pertains to regulatory filings for new and existing products.

Minimum Qualifications:

  • At least 3 years in Regulatory Affairs gaining experience working in medical devices or pharmaceuticals.

Education:

  • Bachelors Degree

Preferred Qualifications:

In addition to the basic qualifications and other required qualifications listed above, the following preferred qualifications also exist:

  • 5 years experience in Quality and Regulatory Affairs in medical devices or pharmaceuticals.
  • Knowledge of global medical device regulations and standards
  • Ability to use/create databases and prepare documents and presentations
  • Bachelor Degree in life science to include Life Sciences, Engineering Sciences, or similar disciplines or equivalent experience
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