Regulatory Affairs Intern in Brea, California at Ormco

Date Posted: 8/24/2019

Job Snapshot

Job Description

Job ID: ORM001611

About Us

Since 1960, Ormco, one of the many successful companies owned by Danaher Corporation, has been developing, manufacturing, and marketing a broad line of orthodontic appliances and related products for sale in the U.S. and abroad. Ormco provides orthodontists with brackets, wires, adhesives, and ancillary supplies used through the course of treatment.

Ormco believes the direct contact of its sales force with orthodontists facilitates the identification and verification of market trends and new product opportunities. Ormco works closely with orthodontists to improve existing products and develop new products primarily through its Champion programs in which selected orthodontists assist Ormco in designing, developing and ultimately educating users on new product and technique innovations.


Description

The Summer Intern: Regulatory Affairs opportunity will help you grow in your educational and career development. During this internship, you will also have an opportunity to:

  • Assess marketing literature to identify claims and work with R&D to ensure data is available to substantiate the claims.
  • Assist R&D in preparing verification protocols to obtain data to support claims.
  • Support the transition of files to the European Medical Device Regulation.
  • Attend project team meetings with RA lead to assist in strategic discussions to hone team collaboration skillset.
  • Candidates must be enrolled in an accredited college/university pursuing a BS or MSc in a scientific discipline (ex: Biology, Biomedical Engineering).
  • Candidates must be available to work Full-time from May through August. Opportunity for conversion of position to full time.
  • Candidates must be legally authorized to work in the United States.
  • Candidates must be detail-oriented, highly organized and able to manage multiple tasks.
  • Candidates must have the ability to work independently as well as on a team.
  • Candidates need to be proficient with Microsoft Office, Word, Excel, Power Point, and have strong oral and written communication skills.


Job Requirements



Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential 

functions.

Education and/or Experience: 

  • Bachelor's Degree from four-year college/university.
  • Working knowledge of medical device regulations including 510k submissions preferred. Knowledge of EPA pesticide antimicrobial regulations and FDA 
  • Drug/device establishment and listings is desirable.

Language Skills: Excellent written and oral communication skills.

Strong analytical and organizational skills; ability for detail and precision.

Mathematical Skills: Good general mathematical skills, strategies and concepts.

Reasoning Ability: Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written or oral form.

Computer Skills: Computer literate in Word, Excel, Powerpoint.

Other Skills and Abilities: Must have the ability to work in a team-oriented environment and is able to meet tight deadlines.

Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available at: http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf.

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Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years.


At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.


Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.