Senior Regulatory Affairs Specialist
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.
- At least 3 years in Regulatory Affairs gaining experience working in medical devices or pharmaceuticals.
- Bachelors Degree
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