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 Director, Quality and Regulatory Compliance, Compliance Programsis responsible forhelping to shape, implement and support the maintenance of theBD Q&RC complianceprograms. This role contributes to the definition of the strategy and determines the tactics required to execute various elements of the program.Through outstanding communication, effective problem solving and active management of ambiguous situations, the Director, Compliance Programsprovides heightened oversight and governance of compliance recovery programs.
The Director works directly with business units and sites to drive enhanced quality and regulatory compliance through coordination, tracking and monitoring of health authority responses, commitments and inspection readiness.
This role requires demonstrated 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 Director will report directly to the VPQuality and Regulatory Compliance and is a member of the Central Quality & Regulatory Compliance Leadership team.
Responsibilities:
Support the Quality & Regulatory Compliance Leadership Team in designing and implementing compliance programs
Provides tactical oversight and tracking of planning and execution of recovery activities
Acts as an independent reviewer/approver on CAPAs and quality plans for assigned compliance recovery programs
Works with business unit/site leadership to ensure adequate and capable associates are allocated to quality and regulatory compliance remediations
Provides guidance to ensure timely execution of activities defined for compliance programs. Ensures compliance program activities align with relevant regulations and BD global processes
Escalates risks to timely and effective completion of compliance programs, including prioritization, resource, capability and documentation concerns
Develop and maintain a set of tools and templates for reporting on status of compliance programs to various levels of management
Perceived as thought leader possessing subject matter expert knowledge of global regulations
Demonstrates a commitment to service, organization values and professionalism through appropriate conduct and demeanor always
Operates with the highest levels of ethics and integrity
Strong problem solving and analytical skills
Maintains confidentiality and always protects sensitive data
Works collaboratively and supports efforts of team members
Must have a working knowledge of the complexities of a global company and ability to operate within a highly matrixed environment
The ability to work effectively with other departments and understand the operational and cultural issues relevant to achieve superior results
Strategic focus, with ability to identify and prioritize the most critical and impactful issues and opportunities to drive long-term success
Ability to develop creative approaches and solutions necessary to resolve complex problems
Qualifications:
Minimum BA/BS degree or equivalent in a Life Science, Engineering, or Physical Science; Advanced technical degree or MBA preferred
Minimum of 10 years of experience, with at least 5 years of management experience in quality, compliance, or regulatory in the MedTech, IVD, or pharmaceutical industry
Recent experience in quality management, compliance or an auditfunction working 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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Primary Work Location
USA CA - San Diego Bldg A&BAdditional Locations
USA NJ - Franklin LakesWork Shift
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.
Salary Range Information
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.