Biomedical Innovations design, development, and manufacturing services are provided to major global medical device companies to support product realization, additionally our proprietary brand of products are produced and distributed to healthcare providers. Through these business models, we aim to extend our capabilities such as product development and design, in order to enhance the value provided to our customers.

Considering a job at Biomedical Innovations?

At Biomedical Innovations, we’re dedicated to working as a team, and encouraging each other to excel every day. As we continue to look for innovative ways to exceed the highest industry standards, we understand how important it is to recruit the right candidates. By aligning with talented individuals who help us deliver quality solutions and ensure consistency in our products and services. Here, you’ll work within a giant melting pot of smart, motivated people who are rewarded for their commitment to doing challenging work that pushes them to learn and grow. Here, your opportunities are endless.


Innovation

Our Leadership Team continues to invest in our associates - Our forward looking culture is like no other.

Health & Wellness

With a focus on healthy mind and body,  we strive to expand health and wellness incentives across our global operations.

Global Force

We bring together leading cultures and innovators - Join our dynamic and a culturally rich work environment.

Changing the World

Biomedical Innovations products change the pace of patient care with innovative wireless monitoring.


Advancement Opportunities

We believe in promoting and growing talent from within! Employees are offered opportunities to apply for open positions.

Compensation and Benefits

Specific benefits will vary by location. In general they include:

  • Competitive Financial Compensation
  • Training and Development
  • Healthcare Coverage
  • Health and Wellness Incentives
  • Disability Protection
  • Tuition Reimbursement
  • Retirement Plans
  • Service Awards

Diversity EEO Statement

Graphic Controls is an Equal Opportunity Employer. Graphic Controls considers applicants for all positions without regard to race, color, religion, creed, gender, national origin, age, disability, marital or veteran status, sexual orientation, or an other legally protected status.

Culture

Employees are offered great benefits and opportunities which make coming to work everyday something to look forward to. Employee satisfaction is proven by the simple fact that our average length of service is over 15 years.


Openings >> Regulatory Affairs Manager
Regulatory Affairs Manager
Summary
Title:Regulatory Affairs Manager
ID:1807
Department:Quality
Location:Buffalo, NY
Description
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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