Compliance Specialist in Thousand Oaks, California at Implant Direct

Date Posted: 4/14/2018

Job Snapshot

Job Description

Job ID: IMP000531

About Us

Implant Direct is one of the fastest growing major dental implant companies in the world today. We’re one of the many operating companies within Danaher Corporation’s dynamic portfolio of dental companies.  



Implant Direct operates a state of the art manufacturing facility in Thousand Oaks, California. We manufacture and distribute a broad range of value priced surgical, prosthetic and regenerative solutions to dental professionals in the US, Canada, and around the globe. We design and develop products which make high quality implants more accessible to patients around the world. We educate dentists on how to place implants and improve their patient care.



If you are interested in working in a lean, fast moving, entrepreneurial environment where you can learn, grow and make a difference, join us at Implant Direct. 


Description

JOB SUMMARY: Under moderate supervision, major responsibilities include application of relevant US and International Laws and Regulations to major compliance activities.  Examples include interpretation and application of Recall regulations found in 21 CFR Parts 7, 806 and 810.  



ESSENTIAL DUTIES:



  • Supports activities for maintaining compliance with ISO 13485, GUDID (Global Unique Device Identification Database), EU Medical Device Regulation and other major regulations, as applicable. 

  • Participates as a member of a cross-functional team supporting compliant and CAPA investigations, Health Hazard Evaluations (HHE) and Recalls.

  • Conducts adverse event/MDR evaluations.

  • Oversees recall execution, closure and documentation, including the initial investigation activities and scheduling and coordinating meetings

  • Maintains and completes all entries in the GUDID.

  • Reviews and coordinates offsite scanning and storage for completed job order packets.

  • Supports Compliance Training efforts.

  • Assists in the development and/or revision of procedures.

  • Prepares reports and coordinates activities as requested. 

  • Acts as the back-up for the Document Control Specialist.


Job Requirements



Qualifications

MINIMUM REQUIREMENTS:  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.



REQUIRED EDUCATION AND/OR EXPERIENCE: Bachelor’s Degree plus two (2) years of relevant work experience or Associates Degree plus four (4) years of relevant work experience required.



OTHER SKILLS and ABILITIES:



  • Bachelor’s Degree in a scientific or engineering field preferred.

  • Strong organizational skills.

  • Ability to read, understand and retain extensive working knowledge of procedures and company documents.

  • Proficient in the use of a computer, MSOffice suite knowledge/experience required.  Knowledge of Google Enterprise a plus.

  • Ability to carry out detailed, written or oral instructions.

  • Knowledge of computer files management software. QCBD preferred. 

  • Ability to produce positive results with a strong sense of urgency.

  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.

  • Knowledge of US and International Medical Device Regulations (e.g. Quality System Requirements and Standards and ISO 13485).



LANGUAGE SKILLS: Ability to clearly communicate and write reports and business correspondence in English.  Ability to effectively present information and respond to questions from groups of managers, clients, customers, and other key members in the company while maintaining a high level of professionalism.  



REASONING ABILITY:  Ability to apply common sense understanding to carry out detailed written and/or oral instructions. Ability to quickly assess large amounts of information and data. The ability to consider and evaluate the interrelationships of numerous factors and to select the best course of action is imperative. In the absence of sufficient information, sound intuitive judgment is crucial to reaching favorable decisions. Certain qualities, including self-confidence, motivation, decisiveness, and flexibility, as well as the ability to communicate effectively, and apply sound business judgment are important. 



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.



While performing the duties of this job, the employee is regularly required to use hands and fingers to handle or feel objects. The employees frequently is required to sit, stand, walk, reach with hands and arms, and talk or hear and will occasionally be required to bend, stoop, kneel and climb stairs.



Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.



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. The noise level in the work environment is usually quiet to moderate.



Implant Direct offers competitive compensation and a generous benefits package. Benefits include: Medical and dental, vision insurance, 401(k) plan with employer match, group term life & AD&D, Flexible Spending Account, Employee Assistance Program, Flexible Spending Accounts, and paid vacation and holidays. Please visit our website at www.implantdirect.com for more information about our innovative company. 



Implant Direct is an equal opportunity employer.  We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law. We maintain a drug-free workplace and perform pre-employment substance abuse testing.



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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 industrial solutions. Our globally diverse team of 59,000 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 #144 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 2,000% over 20 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.