Director Regulatory Affairs

Reporting to the Vice President, Regulatory Affairs.

Responsible for creating and executing regulatory strategies and objectives for pre-market programs in alignment with business needs.These regulatory strategies may influence the scientific or technical direction of product design and/or development.

The Director Regulatory Affairs is responsible for managing RA associates, for ensuring functional excellence, and for establishing collaborative relationships with other functional leaders.

RESPONSIBILITIES Provides regulatory leadership for programs in the pre-market space for the MMS Regulatory Team Works with the worldwide MMS LT members to ensure alignment of regulatory strategies with business objectives and implementation of the strategic plans Assesses regulatory pathways for new products and product modifications; develops regulatory strategies and tactical plans for submissions to FDA and other regulatory bodies Prepares, or directs the preparation of global regulatory submissions.

Identifies and communicates potential risks and mitigations associated with regulatory strategies to stakeholders Directs the preparation of product information for product registrations Monitors Worldwide regulatory developments affecting the Business Group’s Platforms and Programs and communicates emerging opportunities and concerns to stakeholders Represents MMS in interactions/negotiations with global U.S.

regulatory agencies and Notified Bodies; enables / empowers staff to interact and negotiate with regulators Participates in Public Policy and Advocacy efforts in support of the strategic direction Represents MMS in external activities benefiting BD including trade associations, professional organizations, and standards development organizations Manages a staff of regulatory professionals carrying out product submission/registration activities.

Assesses resource requirements based on business priorities and allocates personnel as required to meet these objectives Develops direct reports required competencies, including, but not limited to, regulatory knowledge and ability to apply and communicate this knowledge Conducts training on regulatory issues for staff and for business stakeholders (e.g., Clinical, R&D., Marketing) Reviews and approves labels, labeling, promotional materials, clinical protocols, and clinical reports Plans departmental budget for MMS Regulatory Affairs REQUIREMENTS B.S.

or B.A.

degree in a technical discipline (e.g., engineering, biology, chemistry).

Advanced degree preferred.

RAPS Certification preferred Minimum five years of directly related professional experience (Regulatory) in increasingly responsible positions in the medical device, biologic, or pharmaceutical fields and two years of management experience Experience with Medical devices, pumping systems and electromechanical devices preferred.

Demonstrated ability to resolve problems and to make appropriate regulatory decisions under pressure.

Experience in negotiating with FDA personnel in CDRH .

Demonstrated success in the preparation and completion (including negotiations) of regulatory submissions (PMA, 510(k), IDE) to FDA and other regulatory agencies.

Demonstrated leadership skills.

Demonstrated project management, negotiation, and communication (written and oral) skills.

Demonstrated global perspective, customer focus, cross-functional collaboration and teamwork skills.

Comprehensive knowledge of U.S.

medical device regulations, Good Clinical Practice standards, Good Laboratory Practice regulations, and Quality System Regulation.

Current knowledge of European quality system standards, and requirements under the medical device directive MDD 93/42/EEC and IVD directive IVDMDD 98/79/EC.