|Title:||Regulatory Affairs Manager|
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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