BD (Becton, Dickinson and Company) Sr. Director, Regulatory Compliance and Strategy in Franklin Lakes, New Jersey
Job Description Summary
Senior Director WW Quality and Regulatory Compliance is responsible for developing, executing and maintaining the BDX Global Quality and Regulatory Compliance Strategy; defining and understanding emerging trends and challenges and the Corporation’s readiness to address them. The individual will be accountable for developing strategies and tactics for BD to be a Regulatory, Quality and Compliance leader globally and advising the organization in implementing changes ahead of the point of crisis and thus avoid any surprises throughout the duration of each ASR period.
The Senior Director is responsible for supporting the development and improvement of the Quality, Regulatory and Compliance capabilities, and enhancing and supporting the continuing improvement of performance, across all Regions.
The Senior Director will additionally act as the Quality/Regulatory Business Partner for Legal, Quality, Medical, Regulatory and the Governmental Affairs functions and will provide strategic guidance regarding the impact of compliance issues on overall corporate strategy and operations for all the Regions and provide an overall service for BDX. This person will also help drive proactive regulatory policy engagement with Quality and Regulatory-related committees with external trade organizations, such as FDLI, AdvaMed and MDIC (i.e., Case for Quality, Real World Evidence, etc.)
II. Primary Responsibilities
A. Key Responsibilities :
Responsible for contributing to the development and implementation of the Quality and Regulatory compliance strategies.
Develop short- and long-term strategies:
Work with BD senior leadership in continuing to build a proactive, collaborative relationship with the FDA and other WW regulatory bodies, including annual BD/FDA meetings.
Provide support, as needed, to the business unit Quality, Legal and RA teams in response to FDA 483’s, Warning Letter’s, etc., to drive timely resolution to regulatory issues.
Provide leadership guidance to the Quality Compliance team regarding post market compliance within the Regions and ensuring effective Agency reporting as required
Drive strategy and change management to help mitigate regulatory compliance risk of BDX globally with U.S. FDA, European and other national or local regulations and standards, as appropriate.
Actively contribute to key strategic decisions impacting the development of BDX business and compliance policies, processes and procedures
Influence regional regulations and standards development
Provide leadership and guidance in the preparation of information and updates to the BD Board of Directors, Quality and Regulatory Committee (QRC)
Partner with and build strong relationships with internal leaders across all Segments, Business Units, and Functions within BD.
Provide interpretation of existing and emerging regulations, guidances, etc. and make recommendations for changes in quality systems, policies or procedures.
Establish programs and policies for:
Compliance trends impacting BD businesses worldwide
Post market, future requirement “sensing” and interpretation
Regulatory agency interaction and engagement
Represent BD as appropriate in industry trade groups (AdvaMed, MDIC), and provide the BD point of view to actively influence the development of industry positions that may impact the regulatory compliance environment, working closely with the BD Regulatory Policy and Public Policy teams in Washington DC.
Make contacts as needed to develop continual input concerning pertinent regulatory, scientific, legislative and compliance activities affecting the industry.
- Advanced degree highly desirable (MS, PhD); scientific or engineering Bachelor’s degree required
Minimum of 15 years of experience.
Demonstrated comprehensive expertise in the applied interpretation of the US & preferably worldwide regulatory standards and laws applicable to the medical device industry, e.g., ISO, QSR, GMP, GLP, GCP, EMD, IVD, AIMD Directives.
Knowledge of and experience in post-market regulations including regulatory and risk management processes.
Excellent written and oral communication and organizational, project management skills.
Experienced in all regulatory compliance aspects of the business: pre-market, commercial, post-market, and regulatory.
V. Required Knowledge and Skills
Excellent verbal and written communications skills
Strong negotiation and facilitation skills
Strong project coordination and management skills of a multicultural team
Ability to project himself/herself as a leader within multiple cultures and motivate teams for which he/she does not have direct accountability.
V. Required Travel
- 10-20% travel (mostly US)
Primary Work Location
USA NJ - Franklin Lakes
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.