Regulatory Affairs Specialist with 1-3 years of experience. Primary responsibilities include being the regulatory representative on product development teams to develop global regulatory strategies and US 510k documents with input from the Director of Regulatory Neurosurgery. Experience writing a 510k is a must, international regulatory experience is a plus.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The Regulatory Affair Specialist:
• Supports Regulatory Director and other Regulatory team members in developing partnerships with operations, manufacturing, Quality Systems, Engineering, Development and our International Division in designing and enhancing regulatory initiatives to facilitate overall regulatory compliance.
• Responsible for regulatory functions including planning and filing of documentation with domestic and international agencies (EU), compliance with regulations and ensuring customer requirements are met.
• Obtains/generates information to be submitted to regulatory authorities and prepares required regulatory submissions.
• Supports new product Design Control process as relates to regulatory inputs and decisions, participates in generation of product requirements, risk analysis, labeling and other design control documents.
• Provides regulatory guidance to clinical affairs, product development, marketing and manufacturing groups.
• Coordinates and prepares 510(k) Premarket Notifications, IDEs, PMAs, Design Dossiers, Technical Files, and periodic reports, as required.
• Prepares responses to FDA and Notified Body letters, supplements, and amendments
• Participates in regulatory audits/inspections as required.
• Reviews and approves product labeling and promotional materials for compliance with regulatory approvals and regulations.
• Reviews and approves MDR related to Neurology products
• Writes departmental SOPs as needed.
• Keeps apprised of new regulations, standards, policies, and guidance’s issued by relevant regulatory authorities that may impact the company.
• Read related regulatory publications and documents; presents information about current regulatory actions.
• Performs all other related duties as directed by supervisor and management.
Bachelor’s degree, preferably a Master’s degree in science or other technically related field, or equivalent work experience. RAPS certified highly desirable
Type and number of years of experience
Must have experience writitng a 510(k) Premarket Notifications. Developing international registrations a plus
Must possess and demonstrate an understanding of FDA, International ISO Standards, Medical Device Directives (93/42EEC), Canadian Medical Device Regulations and other International Regulation regulatory requirements. Must have strong writing, project management and communication skills.
Integra LifeSciences Corporation
Website : http://integralife.com