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.
Responsabilidades
Job Description Summary
The statements below are intended to describe the general nature and level of work being performed by associates assigned to this job. This job description is not intended to be an exhaustive list of all responsibilities, duties, and skills required of associates so classified.The Senior Coordinator Post Market Quality, Field Action Operations is based in North America and reports to the Manager, Post Market Quality, North America. The job holder is accountable for the execution of Post Market Quality Operations, including, field action execution, reconciliation, and creation of monthly status reports across all business segments in North America. This role entails interacting with internal and external customers in the field action process from inception to completion.
The job holder collaborates in the execution of Post Market Quality Operations organization, including, the creation of field action documentation (customer letter, 806 report, etc.), field action execution, reconciliation, and creation of monthly status reports across the Medical, Interventional and Life Sciences segments.
The job holder ensures the timely execution of all processes under their accountability and monitoring performance against metrics to ensure compliance to all relevant global regulations and to ensure customer expectations are met. This should be achieved through outstanding communication, effective problem solving and active management of ambiguous situations.
The job holder will be part of the North America Post Market Quality organization. In this capacity, the job holder will contribute to the overall growth and success of the PMQ NA organization and participate in initiatives as opportunity arises. As such the job holder needs to be able to operate across teams and align with BD’s Values and Strong Teams Operating Model to support delivering the goals of the function efficiently and effectively.
This role will interact with all levels within the organization as well as customer facing. The associate must work independently with minimal supervision.
Job Description
We are the makers of possible
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.
Responsibilities
Primary Duties (essential functions) include, but are not limited to:
Timely execution of field actions within North America.
Assists in the analysis of recall data and maintenance of the databases and in generation of performance metrics.
Interacts with internal and external customers in the field action process from inception to completion.
Submission of monthly status reports.
Accountable for the effective execution of the end-to-end field action processes and appropriate customer concern of issues in compliance with Quality Management Systems and Regulatory Requirements.
Support model of technology/ applications used in field action execution.
Ensure the process, organization, tools are in place to improve the customer experience and meet regulatory and Quality Management Systems requirements.
Lead initiatives to streamline field action related activities.
Support / lead initiatives to drive operational excellence and promote commonality in processes and tools across Business and Regions
Lead and support organizational change readiness to adopt process initiatives and reinforce the need for change so efforts are sustained long-term
Evaluate and implement field action processes from both tactical and strategic perspectives to assure quick customer resolution and partner concern of issues.
Primary responsibilities are:
Interacts with external customers in the field action process from inception to completion.
Implements the logistical processes for BD field actions, including but not limited to:
Communicating with distributors regarding customer information.
Conducting all administrative activities such as faxing, mailing, and filing of recall notifications.
Maintaining customer information.
Facilitating the replacement process with customer service and/or field service.
Conducting recall effectiveness checks.
Experience & Education
High school diploma or GED required.
Associates degree or minimum 2 years of regulatory or customer service preferred
Prior people leadership experience highly preferred.
Working knowledge in the applied interpretation of worldwide regulatory standards and laws applicable to the medical device and / or in vitro diagnostics industries, e.g., 21 CFR Parts 7, 806, 21CFR820, ISO 13485, HC 63 to 65, etc. is preferred.
Excellent written and oral communication and organizational, project management skills.
Ability to continuously assess the effectiveness of functional processes and to lead progressive improvement initiatives applying principles of process excellence.
Motivated to improve organizations and not be satisfied with status quo.
Problem identification, analysis, and formulation of conceptual / technical and business solutions
Leadership Competencies
Leading Courageously Takes personal ownership on important issues in order to do what is right and achieve organizational success and supports others who do so. Challenges decisions where appropriate.
Influences Others Presents a compelling case for ideas and initiatives via an appropriately chosen strategy to gain stakeholder commitment.
Using Insightful Judgment Identifies and analyzes information to make decisions and solve problems.
Building Relationships and Promoting Collaboration Develops and maintains constructive, open, and honest relationships with others; facilitates the effective interaction and contribution of others to achieve goals.
Inspiring Trust Gains others’ confidence and trust through principled leadership and sound business ethics.
Focus on Customers Works closely with customers to analyze and understand their needs and requirements.
Execution and Driving for Results Plans and executes work processes while demonstrating a strong sense of urgency and commitment to achieving goals.
Developing People and Talent Focuses efforts on identifying, evaluating, and developing talent, taking steps to ensure needed talent bench strength in the organization.
Strategic Thinking Driven to envision a better future; takes any role or job and makes it better; has relentless dissatisfaction with status quo; makes the customer central to all thinking; keeps the focus on driving customer value; a change agent.
Prudent Risk-taking Inner confidence to take risks and learn from experience; courage to grab opportunities or shed non-viable businesses.
The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job.
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
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.
Required Skills
Optional Skills
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Primary Work Location
USA MD - Sparks - 7 Loveton CircleAdditional Locations
Work Shift
NA (United States of America)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
71 900,00 $ - 118 600,00 $ USD AnnualPerfil 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.