Regulatory Affairs Specialist
The Regulatory 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 participate in development of regulatory strategies to gain approval of new products, new intended uses for existing products, and existing products in new regions.
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, or to support the introduction of existing products into new geographies.
- Works with the franchise and 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 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
- Building trust
- Facilitating change
- At least 2-5 years experience working in an regulated environment, such as medical devices.
- At least 1-3 years Regulatory Affairs or Quality experience working in medical devices or pharmaceuticals.
- 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:
- Knowledge of global medical device regulations and standards
- Ability to use/create databases and prepare documents and presentations