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Rep, Product Surveillance I

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Quality
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186753 Requisition #
Thanks for your interest in the Rep, Product Surveillance I position. Unfortunately this position has been closed but you can search our 420 open jobs by clicking here.
Requirements
  • 2-3 years previous experience in customer service or clinical setting; or equivalent combination of education and experience.
Preferred Skills/Qualification
  • Ability to read, analyze, and interpret common scientific and technical journals, financial reports, medical reports, and legal documents.
  • Ability to respond to common inquires or complaints from customers, regulatory agencies, or members of the business community.
  • Ability to use word processing, spreadsheet, and database applications.  Ability to learn various software programs.
  • Ability to handle confidential data in accordance with HIPAA and related international standards.
  • Ability to function in a controlled environment regulated by the FDA and other regulatory authorities.  The specific requirements include, but may not be limited to: Knowledge of current MDR regulations, guidelines, and interpretations.
  • Vigilance reporting as prescribed within EEA, EAME, APAC and LATAM regions.  Includes Council Directive 93/42/EEC June, 1993 (Medical Device Directive) and other country/regional medical device regulation.  Expertise of any transpositions by countries within the EEA.
  • Knowledge of FDA’s 21 CFR Part 820 (Quality System Regulation), 21 CFR Part 803 (MDR Regulation) and 21 CFR Part 11 (Electronic Records; Electronic Signatures).  
  • ISO 13485:2016, ISO 14971, the Canadian Medical Device Regulations 1998, SOR/98-282, and the Australian Therapeutics Goods Administration regulations (as applicable) at an advanced level.
  • Knowledge of clinical, surgical techniques and procedures, and medical terminology.
  • Skill in demonstrating a professional phone manner.
  • Effective communication with physicians and nurses as required.
  • Expertise in complaint policies and requirements.
  • Ability to communicate effectively, orally and in writing, with employees and all other internal and external contacts.
  • Ability to learn about Allergan Medical’s products and procedures/techniques associated with their use.
  • Ability to take initiative and make decisions.
  • Ability to accurately perform detail-oriented work.
  • Ability to be flexible in changing daily workload priorities as directed.
  • Ability to maintain accuracy, consistency, and quality in a fast-paced, multi-task environment.
  • Ability to participate in multiple projects.
  • Ability to manage a high-volume case load.
  • Ability to think critically and analytically to evaluate each record on a case-by-case basis.
Education
  • AA degree; Bachelor’s degree is preferred.

Equal Employment Opportunity Employer


Allergan is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other protected status.

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