Quality and Regulatory Specialist

Ferris Mfg. Corp.; Fort Worth (TX); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading DFW-based Medical Device Manufacturer seeks a Quality and Regulatory Specialist to ensure compliance with national and international regulations. The role includes preparing regulatory documents, supporting audits, and assisting in product quality assurance. Candidates should have a BS in Science or Engineering and preferably 2+ years of experience in the medical device field.

Qualifications

• 2+ years in quality/regulatory management in the medical device field preferred.
• Experience with ISO 13485, 510(K) submissions.
• Certificate to Foreign Government Application & Approval Process.

Responsibilities

• Prepare and submit regulatory documents for registrations.
• Support internal and external audits for compliance.
• Monitor regulatory changes affecting quality systems.

Skills

Problem Solving

Regulatory Compliance

Quality Management Systems

Documentation Writing

Education

BS in Science or Engineering

MS or MBA

Tools

QMS Software

MasterControl

MS Excel

MS Word

Job description

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DFW-based Medical Device Manufacturer has an opening for a Quality and Regulatory Specialist.This position will perform the following functions while conforming to Ferris policy and procedures and ensuring compliance with national and international laws and standards: assist in assuring the quality of all products and manufacturing; serve, support, and advise internal departments; and serve customer needs and expectations.This position reports to the Manager of Quality & Regulatory.

• Prepare and submit regulatory documents to appropriate agencies for registrations.
• Support compliance with local, national, and international regulations.
• Support internal audits and external audits.
• Keep current with changes in relevant regulations and standards.
• Write NCRs and CAPA’s and resolution.
• Plan and participate in audits with external regulatory agencies, suppliers and customers
• Participate in post market surveillance and recall activities
• Cooperate with top management and department supervisors to promote training, implementation, and enforcement of department procedures
• Participate in addressing and resolving technical problems
• Support Manufacturing, Product Development, Marketing, and Sales
• Support international partners with documentation for registration of products
• Editing and/or drafting policies, procedures, work instructions, specifications, technical documentation, records
• Assist with product complaints and resolutions
• Assist work with clinical staff to generate PMS, CER, PSUR, PMCF reports.
• Monitor laws, regulations, standards, marketplace, and culture for effects on Ferris and quality system.
• Other duties as assigned

Qualifications and Skill Set

• BS in Science or Engineering at a minimum, MS or MBA a plus
• 2+ years quality and/or regulatory management in the medical device industry desirable
• Experience with the use of QMS Software.MasterControl is a plus.
• Exceptional problem-solving skills
• Proficient with MS Excel and MS Word
• Knowledge of and 510(K) Submissions
• Experience in ISO 13485 MDSAP and Registration
• Experience with Medical Device Directive:, Technical Documentation and EU MDR
• Certificate to Foreign Government Application & Approval Process
• Salary: Salary commensurate with experience and achievement.

Company Description

Ferris has been Manufacturing and distributing the innovative PolyMem wound-care products worldwide for 32 years. Ferris has received numerous awards including the KPMG Peat Marwick High-Tech Entrepreneur Award and Diagnostic Industry’s Medical Design Excellence Awards.

Ferris Mfg. Corp. established in 1977 is dedicated to the development and manufacturing of innovative wound-care products for the world professional health care market. Ferris is committed to providing innovative and superior quality products and services to our customers. This position is located in our headquarters and manufacturing facilities in Fort Worth, TX.

Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Medical Equipment Manufacturing

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