Job Openings >> Regulatory Affairs Manager
Regulatory Affairs Manager
Title:Regulatory Affairs Manager
Location:Buffalo, NY
At Nissha Medical Technologies, we are seeking a Regulatory Affairs Manager to join our Quality team. In this role, you will ensure compliance of medical devices to FDA, EU, ISO and other international requirements in order to ensure regulatory compliance across multiple manufacturing facilities. Combine knowledge of scientific, legal and business requirements to assure products developed, manufactured and distributed, meet required statutory and regulatory requirements. As the Regulatory Affairs Manager, you will also advise on and coordinate the approval and registration of medical devices. This role provides a crucial link between Nissha Medical Technologies, its products and regulatory authorities, including the FDA, CMDCAS,  EU Competent Authority, Graphic Controls authorized EU representative, ISO registrar and applicable international authorities.  

Essential Job Functions include:
1.    Ensure that products comply with all regulatory requirements
2.    Manage Regulatory approvals with FDA, Health Canada, Notified Bodies, EU Competent Authorities, EU Representative and international authorities.
3.    Conduct regulatory intelligence monitoring activities and advise management accordingly.
4.    Prepare global regulatory approval submissions including 510Ks, PMAs, CE Technical Files, etc. 
5.    Monitoring and setting timelines for filing regulatory variations and renewals.
6.    Ensure product labeling meets regulatory requirements.
7.    Facilitate continual improvement process interfacing with all departments.
8.    Lead cross functional teams toward improvement of QMS.
9.    Development and implementation of Quality and Regulatory-related training programs as required.

Knowledge, Skills, & Abilities
•    3+ years’ experience in the medical device field
•    RAC Certification preferred 
•    Demonstrated proficiency in leading cross functional groups to conclusions
•    Commitment to excellence and high standards. Versatility, flexibility, and willingness to work with constantly changing priorities with enthusiasm
•    Acute attention to detail. Demonstrated ability to plan and organize projects 
•    Proficient on Microsoft Office product (Word, Excel, Access, & PowerPoint)
•    Prior experience with FDA establishment registration, device listing, 510(k) or PMA submissions
•    Prior experience with international submissions
•    Strong understanding of medical device labeling requirements
•    Proven ability to handle multiple projects and meet deadlines
•    Good judgment with the ability to make timely and sound decisions
•    Creative, flexible, and innovative team player
•    Working knowledge and understanding of the basic principles, theories, concepts, and practices in the applicable area of engineering/technical specialization.
•    Excellent written and oral communication skills
•    Ability to work with all levels of management
•    Strong organizational, problem-solving, and analytical skills
•    Knowledge of applicable regulations and standards 

Nissha Medical Technologies (previously Graphic Controls) is a growing Buffalo based Company specializing in printed products for the gaming, medical, and recording supply markets. A global leader in these areas, Nissha is expanding into new markets and is looking for qualified candidates to grow with the Company. An entry level position allows you start with a Company with many growth and promotion opportunities, while providing job stability with an average length of service of over 15 years.
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Nissha Medical Technologies
400 Exchange Street
Buffalo, NY 14204
Nissha Medical Technologies is the medical devices business unit and wholly owned subsidiary of Nissha Co. Ltd., a Japanese publicly held company based in Kyoto, Japan (TSE:7915).
Copyright 2020 Nissha Medical Technologies. All rights Reserved
The OEM trademarks identified herein are the trademarks of the respective OEMs, and not Nissha Medical Technologies. Nissha Medical Technologies disclaims any affiliation, connection or association between it's products and those of the respective OEMs.