Regulatory Affairs Manager (Medical Devices)

  • Full-time

Company Description

Avery Dennison (NYSE: AVY) is a global materials science and manufacturing company specializing in the design and manufacture of a wide variety of labeling and functional materials. The company’s products, which are used in nearly every major industry, include pressure-sensitive materials for labels and graphic applications; tapes and other bonding solutions for industrial, medical and retail applications; tags, labels and embellishments for apparel; and radio frequency identification (RFID) solutions serving retail apparel and other markets. Headquartered in Glendale, California, the company employs approximately 30,000 employees in more than 50 countries. Reported sales in 2017 were $6.6 billion. Learn more at www.averydennison.com.

Job Description

 

  • Responsible for global submissions and requirements related to Class I,II and III medical devices in the EU and Combination Products within the United States
  • Develops global regulatory strategies for new and modified medical devices.
  • Provides leadership to cross-functional teams during new product development.
  • Integral member of the Post Market Surveillance Team.
  • Administers technical guidance and training to cross-functional teams and other RA members including training on procedures, FDA, MDD guidance documents, and international regulation
  • Author submissions for new devices and device change notifications as required
  • May approve manufacturing changes for compliance with applicable regulations (Change Control).
  • Reviews protocols and reports to support regulatory compliance and submissions
  • Approves device labeling for compliance with US, EUand International submissions and applicable regulations. 
  • Works closely with the Notified Body to approve Change Notifications for Class III devices.
  • Support initiatives in support of Quality Management System and other regulatory requirements
  • Complies with U.S. Food and Drug Administration (FDA), Medical Device Directive and international regulations, other regulatory requirements, Company policies, and Quality System requirements. 
  • Maintains cooperative communications/collaboration with fellow employees, customers, contractors, and vendors
  • Performs other related duties and responsibilities as assigned.

Qualifications

  • Bachelor’s degree (BS, BA) (technical discipline preferred) with at least 8 years technical experience
  • Minimum six years medical device regulatory experience, with minimum of 2 years managing direct reports
  • Extensive experience with EU and global medical device regulations and submissions (Class III devices preferred)
  • Ability to work in a fast-paced environment
  • Strong leadership skills, including the ability to meet/ exceed goals to positively impact business results. 
  • Ability to work effectively within a team
  • Strong verbal and written communications with ability to communicate at multiple levels in the organization.
  • Must be able to multi-task and meets deadlines as directed
  • Strong organizational, planning, and follow-up abilities
  • Ability to travel approximately 25%, including internationally

Additional Information

Vancive Medical Technologies, an Avery Dennison business, makes inspired advances that lead to intelligent results. We bring more than three decades of expertise in adhesive chemistry, performance characteristics and production technologies focused on pressure-sensitive adhesives for medical applications. And we use the most advanced adhesive and material technologies to create products that make healthcare easier for everyone. Science is the foundation of everything we do; we combine proprietary technologies and processes with extensive manufacturing capabilities. Vancive has sales, manufacturing and research and development facilities in the U.S. and Europe, which allows us to work seamlessly with partners in any location. Vancive Medical Technologies is headquartered in Chicago, Illinois. For more information, visit Vancive Medical Technologies at www.vancive.averydennison.com.

Avery Dennison is an equal opportunity employer and committed to increasing its diversity.

AVERY DENNISON IS EVERYWHERE YOU LOOK:
We not only embrace change… we drive it. We work hard, push hard, and take brave risks. Our culture is innovative and collaborative - where bold ideas turn into action. We grow strong talent through stretch opportunities only restricted by your interests. We are committed to workplace diversity, both for employees and for the business. We are a force for good, imbedded in industries and communities worldwide. We are challenging ourselves and others to reach higher and think bigger to improve the quality of all life. Avery Dennison is a great place to work for everyone. We offer: 

  • Workplace Flexibility 
  • Structured learning and development 
  • Mentoring program 
  • Competitive total rewards

At Avery Dennison we do what we love and we love what we do.
We look forward to receiving your application.

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