Identification de l’offre d’emploi R-411349 Date d’affichage 09/07/2021 Retour aux résultats de recherche Postuler

Regulatory Affairs Specialist

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 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.

Job Overview:

  • This position is responsible for the development and implementation of product registration dossiers in support of Greater Asia applications.

  • The candidate will be expected to compose, review, and summarize product technical data that is required by regulatory agencies to demonstrate compliance with global regulations and standards.

  • The candidate will be expected to interface and communicate effectively with international business colleagues and regulatory authorities.

  • Knowledge of international regulatory affairs is preferred.

Duties and Responsibilities:

  • Ensures adequate documentation of BD PI’s compliance to worldwide regulations and standards.

  • Prepares and supports international submissions and international product releases in accordance with applicable SOPs.

  • Maintains regulatory affairs files.

  • Develops working relationships with key personnel at the business unit and representatives of international business centers as well as with ministries of health.

  • Participates in new product development teams, as required, to ensure the product is in compliance with all internal and external worldwide regulatory requirements. Reviews, documents, and supports a worldwide regulatory strategy in support of product development goals.

Education and Experience:

  • This position requires a Bachelor’s Degree in Engineering, or one of the Life Sciences, or similar education.

  • Experience in International Regulatory Affairs is preferred. 0-3 years experience in regulatory affairs or relevant field preferred.

  • Knowledge of a second language is a plus.

  • Ability to plan and schedule multiple priorities in a concurrent fashion.

  • Ability to review, collate, and summarize scientific and technical data.

  • Ability to handle master documents, drawings, and specifications with a high degree of confidentiality.

  • Excellent problem solving and analytical skills.

  • Excellent written and oral communication skills.

  • Detail-oriented, methodical, and able to handle regulatory information and submissions with a high degree of accuracy.

  • Complete work with minimal supervision and have the ability to work independently.

  • Knowledge of U.S. and/or international medical device regulations a plus.

  • Proven computer software skills (Windows Word, Excel, Powerpoint, Project, Outlook).

Physical Demands:

  • While performing the duties of this job, the employee may be required to stand, walk, sit and use hands to manipulate tools, controls and office equipment.

  • Work may involve continuous computer use with repetitive motion to wrists, hands and fingers.

  • The employee is occasionally required to bend, lift, reach or stoop.

  • Employee must be able to wear personal protective equipment.

  • Inability to meet one or more of these physical demands will not automatically disqualify a candidate or employee from the position.

  • Upon request, the company may make reasonable accommodations.

Work Environment:

  • The employee may be in an open cubicle environment and must be able to work in a team-oriented, fast-paced environment.

Why join us?

A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.

To learn more about BD visit https://jobs.bd.com/

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.

Primary Work Location

USA AZ - Tempe Headquarters

Additional Locations

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Lieu de l’emploi

Tempe Headquarters

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Lieu de l’emploi

Tempe Headquarters

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«Nous sommes une entreprise qui vise des résultats concrets et où nos associés s’emploient chaque jour à améliorer les soins de santé. De nombreuses initiatives sont en cours pour faire de BD un leader mondial des technologies médicales.»
Anonyme, Franklin Lakes, NJ

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