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JOB DESCRIPTION
Job Title: Quality Assurance/Regulatory Affairs Specialist
Department: Quality Assurance
Reports to: Director of QA/RA
Direct Reports: N/A
JOB SUMMARY:
Helps ensures that the company’s products consistently meet or exceed established
quality standards. Ensure that processes and work practices are documented and are
efficient, effective, and compliant to local, state, federal and international regulations
which pertain to medical device safety and effectiveness, worker health and safety, and
environmental protection. Provide regulatory input to product development, market
strategy, and business planning and resource allocation decisions to ensure full
regulatory compliance with all aspects of the business. Support/execute planned facility
and product development RA strategies. Responsible for day to day Quality System
processes and tasks including Complaints/CAPA, Audits, Deviations and
Process/Product Validations.
JOB DUTIES:
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Ensure that company quality standards for manufactured and
repaired products are adhered to consistently.
Work closely with Product development teams to ensure regulatory
requirements are met on all projects
Prepare Quality Assurance/Regulatory reports and present status in
review meetings.
Prepare reports and documents necessary for Regulatory Agency
submissions or in support of customer QARA needs.
Responsible for complaint and CAPA systems. Provide responses to
customer complaints.
Perform research to determine Regulatory requirements of new
markets & product requirements
Communicate and advise customers on Regulatory issues
Travel as required.
Perform other duties as assigned.
Perform annual internal regulatory audits and inspections and report
findings to management.
Respond to safety inspection findings.
Provide safety and quality system training to employees.
Maintain current procedures.
Quality Assurance/Regulatory Affairs Specialist
Job Description
Page 2 of 4
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Conduct process, method and root cause analyses.
Prepare 510K and CE Marking submission documents and maintain records.
Prepare a variety of written correspondence and documents.
SKILLS AND QUALIFICATIONS:
Knowledge and complete understanding of Quality System Regulations/cGMPs and ISO
13485 Quality System Standard. EU medical device regulations a plus. Ability to work
with mathematical concepts such as probability and statistical inference. Ability to apply
concepts such as fractions, percentages, ratios, and proportions to practical situations.
Ability to analyze trends and draw logical conclusions.
Must be proficient in Microsoft Word/word processing and Excel/spreadsheet as
essential skills. Proficiency in Access and ERP systems a plus. Critical thinking,
facilitation, negotiation skills and collaboration abilities essential.
ACCOUNTABILITIES:
 Manage and monitor the Regulatory and Safety issues and advise management on
a timely basis
 Develop new ideas and strategies to improve procedures or policies.
 Ascertain integrity of procedures.
 Ensure that work is being performed in accordance with documented procedures.
 Seek to improve and make changes in procedures to document “best practices”.
 Keep up with all regulations and stay informed of organizational changes.
 Remain well prepared for audits by external agencies/organizations (including, but
not limited to FDA, ISO, EPA, OSHA).
 Sustain safe work environment.
Quality Assurance/Regulatory Affairs Specialist
Job Description
Page 3 of 4
EDUCATION AND EXPERIENCE:
Bachelor of Science strongly desired. Experience preferred in in Quality Control, Quality
Assurance or regulatory affairs. Three or more years of experience in Quality with
manufacturing background. . Must have experience working with ISO Quality System
Standard and Quality System Regulations. Must have background working regulated
environment. Experience in industrial hygiene/safety, government regulations, EC
Directives, ISO, operational auditing, work flow analysis, adult learning/training,
technical writing, and manufacturing operations preferred.
INTERPERSONAL AND COMMUNICATIONS SKILLS:
Position requires regular contact both inside and outside the company at all
organizational levels in order to carry out company business, policies, procedures, and
regulations. Involves considerable tact, discretion, and persuasion in order to obtain
willing action and consent. Regular contacts include, but are not limited to, the company
President, QARA, Production Management and Engineering. Contact with employees,
customers, vendors and regulatory agencies/registrars is frequent.
REASONING ABILITY:
Ability to define problems, collect data, establish facts, and draw valid conclusions.
Ability to interpret an extensive amount of technical instructions in mathematical or
diagram form and deal with several abstract and concrete variables.
LANGUAGE SKILLS:
Must possess ability to read, write, speak, and comprehend the English language.
Ability to read, analyze, and interpret general business periodicals, professional journals,
technical procedures, standards, or regulations. Ability to write reports, business
correspondence, and procedures. Ability to effectively present information and respond
to questions from groups of managers, customers, or the general public.
SUPERVISION RECEIVED:
Supervised by Director of QA/RA.
Quality Assurance/Regulatory Affairs Specialist Job Description
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SUPERVISION EXERCISED:
MENTAL, PHYSICAL AND VISUAL DEMANDS:
Position entails some travel. Ability to work under pressure of deadlines is necessary.
Physical demands include working with hands and visual demands entail close vision.
ACKNOWLEDGMENT:
This position description has been reviewed and discussed with me.
Employee:
Date:
Print Name: ________________________________________