Ready to make a difference by utilizing your talents? Join a team driven by a mission to help patients, and a culture focused on developing medical device and diagnostic solutions.
Surmodics is pursuing highly differentiated medical devices that are designed to address unmet clinical needs and engineered to the most demanding requirements. This key growth strategy leverages the combination of the Company’s expertise in proprietary surface technologies, along with enhanced device design, development and manufacturing capabilities. The Company mission remains to improve the detection and treatment of disease.
The Staff Regulatory Affairs Associate supports activities associated with Surmodics’ compliance to all applicable local, state, federal and international regulations, standards, and directives; supports customer regulatory filings and product stewardship issues; and follows regulatory trends that may affect Surmodics’ or our customers’ ability to conduct business. Must be self-directed and motivated to act while taking on projects of greater complexity under limited supervision.
Regulatory Support (70%)
- Provides Surmodics’ clients and staff support regarding regulatory aspects of Surmodics products implementation and maintenance of Surmodics products into their production lines
- Provides regulatory assistance and responds to regulatory questions asked by clients
- Constructs, submits and maintains Device/Drug Master Files on Surmodics products and provides authorization letters for access
- Participates in hazard analyses when required
- Construct and maintain MSDS’s for Surmodics products
- Compiles all materials required in submissions (FDA, TSCA, MCA)
- Keeps abreast of all regulatory procedures and changes
- Assists in the development of systems to support clinical activities
Regulatory Compliance Assessment (30%)
- Assesses regulatory requirements to the following government agencies: FDA, USDA, OSHA/MNOSHA, EPA/MPCA, NAFTA. Communicates findings to management and recommends programs/procedures to assure compliance
- Assess necessity for submitting a 510(k) application for proposed device changes. Prepare internal “Non-Filing Justifications” (U.S.) for changes that do not require a 510(k) submission
- S. degree in Engineering, Chemistry or related discipline
- 7+ years of regulatory experience in a medical device industry
- Knowledge of Regulatory requirements for devices and/or pharmaceutical credentials
- Comprehensive technical skills/knowledge
- Advanced problem-solving skills
- Advanced written and verbal communication skills
- Computer skills appropriate for work responsibilities
- High attention to details
- Excellent interpersonal skills
Surmodics offers a competitive compensation and benefits package, including a bonus program, 401(k) with employer match, employee stock purchase plan and stock options.
Surmodics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.