The Senior Regulatory Affairs Specialist, at the direction of Regulatory Affairs Manager/Director, will prepare regulatory filings to allow for KCI products to be marketed globally. This position will support a business franchise will participate in development of regulatory strategies to gain approval of new products and existing products in new regions and changes to existing products.
Principle Responsibilities: (essential job duties and responsibilities)
•Prepares submissions and compiles documentation in support of domestic and international product marketing approvals. Regulatory submissions may be related to new products, new intended uses for existing products, and introduction of existing products into new geographies.
•Works with the franchise and sustaining engineering teams to establish global regulatory strategies and plans needed to obtain the appropriate regulatory clearances/approvals for new and existing products.
•Reviews proposed modifications to intended use, design, labeling, materials, and manufacturing processes to assess impacts existing regulatory approvals/clearances. Works with teams to develop strategies and plans to manage the implementation of changes.
•Assists design and development teams in developing and documenting appropriate design controls needed to support planned global regulatory submissions
•Reviews Engineering Change Plans and provide input outlining impacts to existing and in-process regulatory approvals/clearances.
•Maintains open communications with local country representatives, including distributors, and local regulatory agencies as required.
•Read and understand global regulations and provide regulatory advice, as required.
•Reviews product labeling to assure compliance with regulations.
•Prepares and maintain regulatory files and tracking databases.
•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.
Skills and Experiences:
•Proficiency with Microsoft Office business software.
• Ability to work effectively with all employees and external business contacts while conveying a positive, service oriented attitude.
•Ability to be self-directed in work activities.
• Ability to communicate effectively, orally and written.
• Ability to maintain confidentiality and discretion in business relationships and exercise
•Driving for results
•Leading through vision and values
•Building a successful team
•At least 5-7 years experience working in an regulated environment, such as medical devices.
•At least 3-5 years Regulatory Affairs experience working in medical devices or pharmaceuticals.
•Experience compiling and submitting 510(k)s.
•Experience compiling and submitting technical documentation to support CE mark.
•Bachelors Degree in life science to include Life Sciences, Engineering Sciences, or similar disciplines or equivalent experience.
In addition to the basic qualifications and other required qualifications listed above, the following preferred qualifications also exist:
•Experience in labeling, advertising and promotional material review
•Knowledge of global medical device regulations and standards
•Ability to use/create databases and prepare documents and presentations
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 status.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