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 careWe 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.
Regulatory affairs (ra) specialist will be responsible for the support and/or preparation of regulatory submissions required to market new or modified medical devices in both domestic and international marketsThis responsibility entails development, execution of procedures and systems designed to ensure that the product development process, including clinical studies, addresses all regulatory requirements as well as the objectives of the business.
This role may be based onsite in tempe, az or may be 100% remote from anywhere within the us with ability to travel to tempe on occasion.
Essential / key job responsibilities (including supervisory and/or fiscal):
Assists or has ownership in the preparation of new product marketing submission for the fda (510k, pma).
Maintains regulatory databases/systems for key regulatory data.
Provides guidance on requirements to product development teams.
Develops strategies for submissions to fda and other regulatory agencies.
Reviews engineering change orders, design change notices and other deviations for compliance with fda, european and international regulations and standardsSends out notifications of change to the notified body as required.
Supports international regulatory requests.
Assist in the preparation of division procedures to ensure compliance with regulatory and corporate requirements.
Understands labeling global regulatory requirementsReviews and approves ad/prom and labeling.
Required qualifications:
Ability to plan and schedule multiple priorities in a concurrent fashion.
Ability to review, collate and summarize scientific and technical data.
Excellent problem solving and analytical skills.
Good 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 ability to work independently.
This position also requires excellent writing and strong organizational skills.
Preferred qualifications:
Regulatory experience
Education and/or experience:
Bachelor’s degree or advanced degree in technical area such as biology, chemistry, engineering or medical-related field.
Minimum of 0-2 years of ra related experience.
Physical demands:
While performing the duties of this job, the employee is regularly required to stand, walk, sit, use sight, and use hands to manipulate, handle or feel objects, tools, controls, and office equipmentThe employee frequently is required to verbally communicate with other associatesThe employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.
Work environment:
While performing the duties of this job, the employee may be in an open cubicle environmentCandidate must be able to work in a team-oriented, fast-paced environmentBd is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.
This job description is intended as a summary of the primary responsibilities of and qualifications for this positionThe job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.
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 workHere 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 cultureOur 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 employerWe 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 az - tempe headquarters
Additional locations
Work shift
