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 provides regulatory support to the Company’s whole product solution strategy throughout the research, development, clinical, and commercial phases of the Company’s vascular medical device products. This role is part of a team composed of U.S. and Ireland - based employees that develop and commercialize products that integrate the Company’s coating, catheter, thrombectomy, and balloon technologies, including products in the Company’s drug-coated balloon programs. This position is responsible for coordinating, preparing, and maintaining regulatory submissions on a global level including European CE-marking and US FDA submissions. Primary responsibilities include providing technical guidance and regulatory support to cross-functional product development teams, maintaining and enhancing cross-functional team relationships, identifying relevant standards and guidance documents that affect business and products, assisting with regulatory agency audits. Must be self-directed and motivated to act while taking on projects of greater complexity under limited supervision.
Regulatory Support (70%)
- Evaluates potential global regulatory pathways for US, EU, and International product launches / product enhancements as an active member of Product Development team(s).
- Prepares regulatory submissions to regulatory authorities, including the FDA, Notified Bodies, Health Canada and other regulatory authorities.
- Interacts directly with regulatory agencies on products / projects at reviewer level. Interacts with various levels of management, external agencies and companies.
- Maintains and enhances cross-functional team relationships. Works with engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies. Provides technical guidance and regulatory training / mentoring to other Regulatory Affairs employees and cross-functional teams.
- Provides support for commercialized products as necessary by reviewing labelling, promotional materials, and product and documentation changes per policy and procedure.
Regulatory Compliance Assessment (30%)
- Maintains expertise in worldwide regulatory requirements, with an emphasis on MDR; establishes and maintains positive relationships with regulators.
- Identifies guidance documents, international standards, consensus standards and assists teams with their interpretation.
- Participates in and assists with Notified Body Audits, MDSAP, FDA facility inspections, and other governmental inspections, as directed.
- B.S. degree in Engineering, Chemistry or related discipline
- Minimum of ten (10) years within a Medical Device or regulated industry with at least seven (7) years of those years working in regulatory affairs. Class III PMA device experience required.
- Demonstrable detailed working knowledge of the medical device and/or pharmaceutical industry and the regulatory environment in which the business operates including FDA, European (MDD and MDR), FDA, Health Canada, and other International Regulatory requirements.
- A self-starter that applies their own initiative in most situations.
- A good team player, who works well in a small team environment, must be able to work effectively with peers in other departments.
- A good communicator who can easily convey their standards and requirements across all levels in the organization and demonstrate confidence and presence in front of external regulatory body personnel.
- Displays the highest levels of integrity and a demonstrated ability to influence their peers.
- Attention to detail and ability to stay connected to multiple projects simultaneously.
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.