Regulatory Affairs Specialist
Job Description SummaryThis position will provide Regulatory Affairs (RA) support for product remediation projects, process and systems remediation projects, and the preparation of regulatory submissions required to legally market medical devices in the European Union under the MDR. This role will provide support for global product registrations and related regulatory affairs activities, as required. This role will appropriately execute project activities based on applicable products and systems which are designed to ensure that the product development process adheres to all regulatory requirements as well as objectives to the business. The candidate is expected to utilize project planning skills to initiate, plan, and execute regulatory projects and submissions with support of supervisor. The candidate must be able to manage change and be flexible when providing solutions. The candidate will be expected to collaborate with their regulatory team, cross functional team members, and regulatory agency partners by building strong and effective working relationships.
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.
This position is a temporary assignment which will include benefits such as (medical, health, dental, 401k). Eligibility for these benefits will be based on the eligibility requirements as determined by the BD Total Rewards policy.
Essential job functions:
Understands and has working knowledge of European Medical Device Regulations. Supports US and international product submissions/registrations, as needed.
Participates in product core teams as required to ensure that the product is in compliance with all internal and external regulatory requirements. Develops, documents and implements a regulatory strategy plan around remediation goals.
Initiates and updates regulatory registrations as required and per applicable SOPs.
Reviews and approves change orders for compliance with FDA, European and/or global regulations and standards.
Provides general support for regulatory team and special projects, as needed.
Assists in the preparation of division procedures to ensure compliance with EU MDR, and other Regulatory and Corporate requirements.
Ensures adequate documentation of BDPI’s compliance to FDA, European and global regulations and standards. Ensures maintenance of regulatory documentation.
Excellent written and oral communication skills.
Proven computer skills (Microsoft Word, Excel, PowerPoint, Project, Outlook).
Demonstrated problem solving and analytical skills.
Ability to plan and schedule multiple priorities in a concurrent fashion.
Ability to review, collate and summarize scientific and technical data.
Detail-oriented, methodical, and able to handle regulatory information and submissions with a high degree of accuracy.
Solid project management skills.
Experience working with others in a team environment.
Education and/or experience
This position requires a Bachelor’s degree or advanced degree in a technical area such as biology, chemistry, engineering or medical-related field.
A minimum of 2+ years employment in Regulatory Affairs, areas of product registration, compliance, or quality systems is preferred.
Experience with European Medical Device Regulations is preferred.
Experience with Kits and Procedure Packs is preferred.
Physical Demands: While performing the duties of this job, the employee is regularly required to stand, walk, sit and use hands to manipulate, handle or feel objects, tools, controls and office equipment. The employee frequently is required to talk and hear. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.
Work Environment: BDPI is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce. While performing the duties of this job, the employee may be in an open cubicle environment. Candidate must be able to work in a team-oriented, fast-paced environment
Employment at BD is contingent upon the Company’s receipt of sufficient proof that you are or will be fully vaccinated against COVID-19. 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 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 LocationUSA AZ - Tempe Headquarters
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Approbationdu Présiden et Chef de la direction
«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