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Benefits OfferedMedical, Vision, 401K, Life, Dental
POSITION: Regulatory Specialist
SUPERVISED BY: Director of Quality Assurance and Regulatory Affairs
SUMMARY: The role of the Regulatory Specialist is to ensure compliance of Buffalo Filter products and services with the regulatory requirements of the markets where they are sold. The Regulatory Specialist will maintain the current requirements of quality system regulations and will be responsible for assisting the Director of Quality Assurance and Regulatory Affairs in achieving the company’s compliance objectives and providing regulatory support to meet customer’s expectations.
Duties & Responsibilities
- Participates in medical device regulatory agency audits and inspections; customer audits and visits.
- Responds to regulatory requests from customers regarding compliance of products to requirements of the European Union, FDA, Health Canada, TGA and regulatory authorities in other countries where products are marketed.
- Interacts with suppliers to gather compliance data for components of products to ensure Buffalo Filter product regulatory requirements are met.
- Generates and maintains procedures required for regulatory compliance.
- Submits eMDR reports to FDA and vigilance reports to other countries when needed.
- Identification and implementation of continuous improvements for the Quality System.
- Preparing and maintaining Technical Files and submissions of license applications and renewals.
- Determining regulatory content and reviews and approves the design of product labels and marketing literature. Submits required UDI data to FDA, Eudamed and other databases as needed.
- Serves as regulatory representative to product development teams and participates in product design reviews. Reviews and approves compliance documentation during the product development phase of new and revised products.
- Facilitates movement of products through customs and across country borders by providing appropriate compliance data and harmonized codes.
- Searches and reviews new regulatory requirements as published by authorities for applicability to Buffalo Filter and submits reports of the review for addition to the management review meeting.
- Prepares post-market surveillance and clinical evaluation reports as needed to keep Technical Files current.
Education & Qualifications:
- Bachelor’s Degree in a technical discipline is required. RAC preferred.
- Minimum of five years of experience in medical device or pharmaceutical industry is required.
- Ability to work independently and in a team environment with minimal supervision is essential.
- Knowledge of FDA, ISO, EU MDR, CMDR, MDSAP, RoHS, REACh and International regulations is essential
- Excellent communication, organizational and multi-tasking skills, and ability to write effectively is required.
- Computer literacy in standard office applications (Microsoft Word, Excel, PowerPoint, Outlook, etc.); required. Experience with Global Shop Solutions or other ERP system; preferred.
Work Environment & Physical Requirements
- Work in a standard office environment/manufacturing facility utilizing a computer and normal office equipment (e.g., copier, fax). Exposure to various types of products and materials handling equipment.
1. Work with individuals internal to the organization, including Operations, Quality personnel, and Executives to meet regulatory and customer requirements.
2. Work with individuals external to the organization, including auditors and regulatory bodies to ensure the organization remains compliant.
3. Participate on company teams and committees as appropriate to ensure integration of activities.
About Filtration Group:
As a world leader in filtration innovation, we can provide a filtration solution for every situation. From custom sizing to industry specific materials and coatings, our engineers make sure our customers are covered. We take pride in delighting our customers by providing filtration solutions for every situation.
Posted date: 11 days ago
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