Director of Quality and Regulatory Affairs

As Director of Regulatory Affairs – Compliance Systems and Labeling, you’ll direct regulatory and labeling activities and collaborate with senior teams to define strategy and compliance programs. You’ll play an integral part in launching new products, supporting established lines, and driving initiatives that ensure success across the entire lifecycle. If you thrive on strategic influence and want to champion quality and compliance at a global scale, we’d love to connect with you.

DUTIES AND RESPONSIBILITIES

• Provides strategic direction and operational leadership for regulatory affairs in a business area or region.

• Provides strategic direction and operational leadership for global labeling.

• Develops and communicates effective regulatory strategies to meet established business goals.

• Provides intentional influence to ensure a robust, day-to-day ‘culture of quality and compliance’ exists in the business area or region.

• Acts as an internal champion for quality and regulatory initiatives aimed at improving business systems and compliance.

• Works closely with other senior-level colleagues within and outside of the company to resolve highly complex and sensitive issues.

• Fosters an ongoing proactive relationship with internal R&D, Clinical, Scientific, Quality, Legal, Manufacturing, and Marketing colleagues.

• Influences internal customers as necessary to ensure a successful strategy implementation.

• Directs the professional growth of professional staff by providing individualized guidance, training, and supervision.

• Participates in Management Teams for business areas.

• Develops Regulatory presentation for Regulatory section of Management Review and participates in the meeting.

• Oversees the development of 510(k)s, IDEs, PMAs, CE Technical Files, CE Design Dossiers, NDA’s and ANDA’s and other international regulatory submissions.

• Acts as primary interface with applicable regulatory bodies, presenting strategies and technology communications effectively.

• Acts as Regulatory PRRC and performs required PRRC activities.

• Ensures that all regulatory activities are conducted with the highest integrity in an ethical, legal, and compliant manner.

• Provides support for the development of new products, from design inputs including clinical and regulatory specifications through comprehensive design validation

support

• Determines the adequacy of new products/processes prior to and following commercial distribution.

• Works closely with Quality Assurance to ensure that the Quality Management System is maintained for effectiveness in accordance with applicable standards and regulations.

• Identifies areas of regulatory or compliance risk and develops mitigating strategies.

• Directs compliance programs such as the Standard Assessment program, UDI compliance, and State License program, as well as Regulatory Operations.

• Identifies areas of regulatory or compliance risk and develops mitigating strategies and works to implement solutions cross-functionally.

MINIMUM QUALIFICATION REQUIREMENTS

Education

• Four-year college degree is required, and an advanced degree in the physical sciences is considered a plus.

• Professional education in Regulatory Sciences desired, with regulatory certification a plus.

Experience

• Minimum of 10 years of regulatory experience with increasing responsibility in the medical device or pharmaceutical industry.

• Experience with both sterile disposables and electromechanical medical devices with embedded software preferred.

• Knowledge of the software in medical device regulations is preferred.

• Experience with pharmaceutical submissions (NDA/ANDA in eCTD format) or medical device submissions (510(k), PMA, CE mark, etc.).

• Minimum 5 years of managerial experience with multiple direct reports.

• A demonstrated track record of representing unique technologies to regulatory authorities and gaining timely approvals is critical. Work with drug/device combination products is desired.

• Demonstrated effective leadership and strategic planning skills in environments where regulatory guidelines have not been developed and where creativity can

impact approval timelines.

• Experience working closely with clinical experts in all stages of clinical trials.

• Experience in regulatory compliance requirements desired (Health Hazard Evaluations, Removals and Corrections, Adverse Event Reporting, Promotional

Material review, etc.)

• Direct experience in and knowledge of business and management principles involved in tactical execution, strategic planning, resource allocation, human resources modeling, leadership techniques, production methods, and coordination of people and resources.

• Experience working in Quality or leading a Quality team is preferred.

Skills

• Ability to solve practical problems and interpret and communicate complex regulatory requirements in a manner that allows maximum product flexibility without compromising regulatory compliance.

• Demonstrated ability to select, manage, motivate, lead, influence, and develop regulatory skills in coworkers of varying levels of experience.

• Capacity to define and communicate regulatory challenges and provide guidance to top management by developing and implementing positive and proactive solutions.

• Excellent written and oral communication skills and a proven ability to communicate effectively. Proven ability to read and interpret documents of significant complexity, including external standards, design inputs, verification/validation protocols, and clinical studies.

• Demonstrated ability to interact productively and to effectively influence peers, external colleagues, and senior management.

• Willingness to take ownership and accept responsibility for actions and decisions.

• Regulatory expertise complemented by strong operational, logistical, communication, and business skills.

• Knowledge of current US and non-US regulatory requirements, such as the EU and Canada, and trends affecting medical devices and pharmaceuticals.

• Ability to help the management team balance regulatory requirements with business requirements and identify solutions to meet both sets of needs.

• Strong interpersonal and conflict management skills, maturity, good judgment, and capable of communicating with a diverse range of individuals.

• Must be detail-oriented, well-organized, and able to work both independently and in teams.