Director of Regulatory Affairs responsible for supporting MMS Infusion products globally from a Regulatory Affairs standpoint. Lead and develop direct report associates to ensure regulatory compliance, problem solve and escalate regulatory and compliance issues to senior management as vital. Drive continuous improvement in internal processes and customer satisfaction.
Requirements
- Bachelor’s degree in RA, QA, engineering, or other science related discipline
- Advanced degree (e.g. MS, PhD) preferred
- RAPS RAC certification preferred
- Minimum of 10 years of directly related Regulatory Affairs experience in medical devices and/or in vitro diagnostic field
- Minimum of 7 years of personnel management (direct report) experience including performance evaluations/improvement, and career development
- Software experience including SaMD/SiMD is a plus
- Regulatory and Quality Information Management systems such as SAP, RIM, or related systems
- Digital literacy MS Word, Excel, PowerPoint, Teams
- Project Management experience
- Knowledge of global Regulatory Affairs requirements, regulations and standards
- Experience authoring regulatory submissions (US and Global)
- Strong prioritizing, interpersonal, communication, and analytical skills and the ability to multi-task disparate projects
- Ability to represent Regulatory Affairs in multiple environments (e.g. Marketing, R&D, and compliance) and work with all levels of personnel, including VP/GM
- Ability to partner with cross-functional colleagues to identify opportunities for regulatory innovation
- Read, analyze, and interpret regulatory literature and documents and effectively communicate information to peers and management
- Ability to work within a team environment and independently with minimum supervision
- Identify and communicate risks and mitigations associated with global regulatory strategies to cross-functional collaborators and act upon these items appropriately as an RA member
- Demonstrated leadership courage through openness to diverse views, candor in assessing and articulating difficult positions, and willingness to make changes when needed
- Ability to travel globally up to 10% of the time
Benefits
- Generous Paid Time Off
- 401k Matching
- Retirement Plan
- Visa Sponsorship
- Four Day Work Week
- Generous Parental Leave
- Tuition Reimbursement
- Relocation Assistance
