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Terumo Blood and Cell Technologies · 1 day ago

Director, Regulatory Affairs - Compliance Systems and Labeling

Lakewood, CO

Full-time

Hybrid

Director/Executive

$196K/yr - $246K/yr

10+ years exp

Terumo Blood and Cell Technologies is a global leader in medical devices and related products impacting patient lives worldwide. The Director of Regulatory Affairs will direct regulatory and labeling activities, collaborate on strategy and compliance programs, and ensure quality and compliance across the product lifecycle.

Medical Device

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 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 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

Monitor and drive solutions for changes in regulatory environment that have the potential to impact Terumo BCT business and participate in industry groups for pro-active engagement

Qualification

Regulatory AffairsLabeling StrategiesRegulatory SubmissionsRegulatory ComplianceManagerial ExperienceMedical Device KnowledgeStrategic PlanningQuality ManagementCommunication SkillsInterpersonal SkillsProblem SolvingConflict ManagementDetail Oriented

Required

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

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

Minimum 5 years managerial experience with multiple direct reports

A demonstrated track record of representing unique technologies to regulatory authorities and gaining timely approvals is critical

Demonstrated effective leadership and strategic planning skills, in environments where regulatory guidelines have not been developed and where creativity can impact approval timelines

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

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 management team balance regulatory requirements with business requirements and identify solutions to meet both sets of needs

Strong interpersonal and conflict management skills, maturity and 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

Preferred

Professional education in Regulatory Sciences desired with regulatory certification a plus

Experience with both sterile disposables and electro-mechanical medical devices with embedded software preferred

Knowledge of the software in medical device regulations preferred

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

Experience in regulatory compliance requirements desired (Health Hazard Evaluations, Removals and Corrections, Adverse Event Reporting, Promotional Material review, etc.)

Experience working in Quality or leading a Quality team is preferred

Regulatory Affairs Professional Society (RAPS) Certification (US and EU and/or Canada) or other geographic regulatory certification preferred

Benefits

Multiple group medical, dental and vision plans

A robust wellness program

Life insurance and disability coverages

A variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance

401(k) plan with a matching contribution

Vacation and sick time programs

Company

Terumo Blood and Cell Technologies

Glassdoor3.4

Headquartered in Lakewood, Colorado, Terumo Blood and Cell Technologies is a global leader in blood component, therapeutic apheresis and cellular technologies serving customers in more than 150 countries.

Founded in 1964

Lakewood, Colorado, US

5001-10000 employees