Quality Systems / Regulatory Compliance Specialist

OVERVIEW:About the job:***NO Visa Sponsorship/ No H1Bs/ No C2Cs***Our client, a US Fortune 250 company and a global medical technology corporation serving customers in Clinical Labs, Health care research & Pharmaceutical industry, seeks an accomplished Quality Systems / Regulatory Compliance Specialist. ** JOB #: 3213** JOB TITLE: Quality Systems / Regulatory Compliance Specialist** JOB LOCATION: Hybrid role at 39 Loveton Circle Sparks Maryland 21152** JOB DURATION: Duration: 6-month contract (possible extension)** WORK SCHEDULE: Tuesday–Thursday onsite & Monday & Friday remote 8:00 AM – 5:00 PM ESTPay Rate: $40.00/hr. – $44.00/hr.POSITION SUMMARYUnder general supervision, this role supports customer and internal quality/regulatory requests, audit activities, quality systems maintenance, and regulatory compliance documentation.The ideal candidate will have experience working in regulated environments supporting:Quality systems Regulatory documentation Compliance activities Technical data analysis Audit support This is a strong fit for candidates from:Medical device Diagnostics Biotechnology Pharmaceutical Regulatory compliance environments.KEY RESPONSIBILITIES:Respond to customer and internal requests related to quality and regulatory documentation Provide onsite audit support and assist with audit readiness activities Maintain quality system procedures and related documentation Investigate and resolve moderately complex quality/compliance issues Analyze regulations, standards, and guidance documents to support compliance activities Prepare and maintain documentation for: Ingredients OEM products IVDR compliance Animal by-product regulatory requirements Support maintenance of: USDA permits CDC Import/Transport permits USDA certificates EDQM TSE Certificates of Suitability AOAC-RI certifications Assist with international import/export compliance documentation Support presentations and reporting during team meetings Coordinate with government agencies and international stakeholders as neededJOB REQUIREMENTSBachelor’s degree in: Science, Engineering, Related technical discipline Minimum 3 years of relevant experience or equivalent combination of education and experience Basic knowledge of: Quality systems regulations ISO Quality Systems Medical Device standards Strong written and verbal communication skills Excellent attention to detail and organizational abilities Strong analytical and problem-solving skills Ability to work independently and within cross-functional teams Experience collecting, analyzing, and summarizing technical data Strong Microsoft Office skills, especially: Excel data extraction and analysis SAP proficiency strongly preferredPreferred Qualifications: Project management experience Knowledge of: Global Animal By-Product Regulations USP / EP / JP standards Professional certifications such as: RAC, Six Sigma Experience in: Medical device, Diagnostics, Regulated manufacturing environmentsRecruiter Contact InfoLalit MalgotraEmail: lalit.malgotra@ameritconsulting.comwww.ameritconsulting.comI'd love to talk to you if you think this position is right up your alley, and assure prompt communication, whichever direction. If you're looking for rewarding employment and a company that puts its employees first, we'd like to work with you.Company Overview:Amerit Consulting is an extremely fast-growing staffing and consulting firm. Amerit Consulting was founded in 2002 to provide consulting, temporary staffing, direct hire, and payrolling services to Fortune 500 companies nationally; as well as small to mid-sized organizations on a local & regional level. Currently, Amerit has over 2,000 employees in 47 states. We develop and implement solutions that help our clients operate more efficiently, deliver greater customer satisfaction, and see a positive impact on their bottom line. We create value by bringing together the right people to achieve results. Our clients and employees say they choose to work with Amerit because of how we work with them - with service that exceeds their expectations and a personal commitment to their success. Our deep expertise in human capital management has fueled our expansion into direct hire placements, temporary staffing, contract placements, and additional staffing and consulting services that propel our clients’ businesses forward.Amerit Consulting provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. Applicants, with criminal histories, are considered in a manner that is consistent with local, state and federal laws.