Faça parte de algo maior na BD. Aqui, você nos ajudará a manter nossos altos padrões de uma perspectiva regulatória em todos os níveis, com foco nas submissões. Requer atenção aguda aos detalhes, excelentes habilidades de comunicação e uma paixão para continuar aprendendo e atualizando seu conhecimento, o que o ajudaremos a fazer com oportunidades regulares de aprendizado. Aqui, você usará seu profundo conhecimento das regulamentações e requisitos da FDA, Canadá e ISO/MDD em torno de dispositivos médicos para atingir um objetivo único: Impulsionar o mundo da saúde™. Na BD, você pode fazer a verdadeira diferença de um.
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Job Description Summary
Job Description
Be part of something bigger!
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 70,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.
The Sr. Director, Quality & Regulatory Compliance, Compliance Program position is responsible for the implementation, continuous improvement and management of the BD Q&RC compliance programs. The incumbent is responsible for establishing strategy and direction for BD compliance programs, for defining and understanding emerging trends and challenges, and the organization’s readiness to address them.
This position is accountable and responsible for ensuring effective implementation of the company’s External Audit management processes in alignment with the overall quality strategy as the global process owner. The incumbent functions as a subject matter expert for quality and compliance issues.
This role provides support to the business units/sites, as well as independent oversight and transparency for compliance remediation activities.Directs and supervises designated leaders who have the overall responsibility for the successful operation of BD compliance recovery programs.
The incumbent requires extensive experience working in or with US FDA, Notified Bodies, and other global regulatory authorities. Demonstrate experience with the US FDA GXP regulations and have a working knowledge on quality matters involving the design, development, manufacture and distribution of medical devices, combination products, IVDR, and drug products.
The Sr. Director will report directly to the VP Quality and Regulatory Compliance and is an active member of the Central Quality & Regulatory Compliance Leadership team.
Responsibilities:
- Supports the development and review of external Health Authority and Notified Body observation responses (appropriate response, investigation, corrective actions, timing, execution), complaints and appeals
- Performs independent review of Health Authority documents linked to compliance programs
- Tracks and monitors Health Authority commitments, additional information (AI) responses and remediation project management. Reports on key quality & regulatory compliance indicators
- Supports driving consistency in field action determinations across BD through active review of field action decisions. Acts as an independent consultant to BUs regarding field actions
- Monitors and, at times, facilitates Health Authority interactions
- Participates in BD governance forums supporting independent transparency
- Provides leadership and guidance in timely communication/escalation to Executive Leadership of issues associated with external audit findings, regulatory enforcement actions and compliance risk
- Monitors the external Quality and Regulatory environment to share and incorporate lessons learned across industry as well as from health authorities within BD, to help drive continuous process improvement
- Partners with stakeholders to develop strategies and tools to ensure effective inspection readiness and management across the organization and provides strategic support to the businesses and regions where needed
- Identifies needs and supports enhancing regulatory compliance capabilities through delivery of targeted training
- Provides support to external audit and inspections, as necessary
- Maintain a high degree of personal professional development through a combination internal and external training and participation in professional associations as appropriate
- Perceived as thought leader possessing subject matter expert knowledge of assessing compliance to global regulations
- Manages budgets, schedules and performance standards of regulatory compliance recovery team
Qualifications:
- B.S. a Life Science, Engineering, Physical Science or equivalent discipline, an advanced degree or MBA is preferred.
- Minimum 15 years of experience in a management position or leadership experience with at least 10 years of experience in quality, compliance, or regulatory in the MedTech, IVD, or pharmaceutical industry
- Recent experience in working in or with US FDA, Notified Bodies, and other global regulatory authorities
- Demonstrated comprehensive expertise in the applied interpretation of the US & worldwide regulatory standards and laws applicable to the medical device industry, e.g., ISO, QSR, GMP, GLP, GCP, MDR, IVDR, MDSAP
- Anticipated travel on a global basis to be around 20-40%
For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why Join Us?
A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.
To learn more about BD visit https://bd.com/careers
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.
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USA CA - San Diego Bldg A&BAdditional Locations
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At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.
Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.
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Perfil de Sucesso
What makes a successful Regulatory Affairs Professional at BD? Check out the top traits we’re looking for and see if you have the right mix.
- Analítico
- Colaborativo
- Comunicador
- Persuasivo
- Solucionador de problemas
- Apresentador habilidoso
Impulsionando o mundo da saúde™
BD é uma das maiores empresas globais de tecnologia médica do mundo e está Impulsionando o mundo da saúde™ melhorando a descoberta médica, o diagnóstico e a entrega de cuidado. A BD ajuda os clientes a melhorar os resultados, reduzir custos, aumentar a eficiência, melhorar a segurança e expandir o acesso aos cuidados de saúde.