QA/RA Associate in Warsaw, IN at Tecomet

Date Posted: 7/20/2018

Job Snapshot

Job Description

JOB SUMMARY:

The Regulatory Associate will assist the Regulatory Engineer to ensure that the regulatory-related requirements from our customers are communicated clearly and concisely to all employees while assuring the company meets domestic and international customer and governmental regulatory requirements. This is accomplished by maintaining Tecomet’s principles of Safety, Quality, Customer Satisfaction and Innovations. The Regulatory Associate will also assist the Regulatory Engineer in teaching regulatory sciences and best practices to team members.

Harmonized core technical skills:

  • Working knowledge of government(s), international, and national regulations regarding medical devices (i.e. FDA, MDD, CMDCAS, PAL, ISO etc.)

Harmonized core education and experience:

  • Bachelor’s degree and two years of experience in a quality and regulatory related field or equivalent combination of education and experience.

Preferred:

  • Bachelor’s degree
  • Orthopedic regulatory/compliance experience
  • Accredited Certifications in related fields

 ESSENTIAL FUNCTIONS:


• Field complaint investigations and reporting


• Participate in design reviews


• Assist in the creation/develop regulatory strategies for new projects


• Assist in the maintenance FDA MDL listings/submissions for Symmetry products


• Legalization of documents for ROW countries


• Participate in ISO audits and Technical File Reviews


• Participate in Annual review of all Tecomet products (PMS)


• Effectively document clear and concise audit reports and findings


• Evaluate corrective action in response to observations made throughout audit process


• Conduct special studies, projects, and related duties as assigned by manager


• Additional functions and requirements may be assigned by manager as deemed appropriate

KNOWLEDGE, SKILLS AND ABILITIES:


• Ability to read, analyze, and interpret common scientific and technical journals, technical procedures, and/or government procedures


• Ability to respond to common inquiries or complaints from customers, or regulatory agencies


• Ability to define problems, collect data, establish facts, and interpret technical instructions to draw valid conclusions


• Ability to handle multiple projects simultaneously


• Effective organizational skills


• Computer skills – Proficient in MS Word, Excel, and PowerPoint


• Familiarity with risk management and mitigation


• Manufacturing-related knowledge of medical devices to effectively conduct strategic process adequacy risk assessments


• Team-oriented attitude


• Ability to work in a proactive and reactive environment


• Ability to deal with complex and difficult situations unsupervised


• Ability to maintain confidentiality of information

PHYSICAL AND ENVIRONMENTAL DEMANDS:


• Mobility to move throughout the production facilities and various sites, and to sit for eight (8) or more hours per day.


• Able to communicate quickly and clearly verbally, in writing and by phone.


• Able to perform repetitive, highly accurate keyboard operations for eight(8) or more hours per day and on weekends (if required)


• Ability to read fine print


• Position takes place in a well-lighted, heated/air-conditioned indoor office/production setting with adequate ventilation


• Light physical activity performing non-strenuous daily activities of a primarily administrative nature.


• Manual dexterity sufficient to reach/handle items and work with fingers.


• Ability to wear proper PPE.

TRAVEL REQUIREMENTS:        YES        X    NO                                                           

INTENT AND FUNCTION OF JOB DESCRIPTIONS:

Requirements, skills, and abilities included have been determined to be the minimal standards required to successfully perform the positions.  In no instance, however, should the duties, responsibilities, and requirements delineated be interpreted as all inclusive.  In accordance with Americans with Disabilities Act, it is possible that requirements may be modified to reasonably accommodate disabled individuals.  However, no accommodations will be made which may pose serious health or safety risks to the employee or others or which impose undue hardships on the organization.Job descriptions are not intended as and do not create employment contracts.  This organization maintains its status as an at-will employer.  Employees can be terminated for any reason not prohibited by law. Tecomet is an EOE M/W/VET/Disabled