• Assists with product registration requirements worldwide by helping to:
  • Provide regulatory support and guidance to assigned product teams.
  • Assemble documentation required for annual renewals of establishment registrations, device listings and licenses (domestic and international).
  • Determine regulatory pathway and provides complete global regulatory assessment of product changes, including submission of product registrations
  • Provide regulatory support for international registrations and requests for documentation, and support for registration of portfolio products in new markets
  • Review and approve product labeling and advertising
• Provide support in preparing US and non-US product submissions (510(k), Technical files, Canadian Licenses and International Registrations).
• Assists to support domestic (federal, state, and local) and International products registrations by obtaining documentation for:
  • Certificates to Foreign Governments (CFGs),
  • Apostille,
  • Consularization seals and certification
  • Other certifications as required
• Helps to provide RA product registration/approval/clearance information to help expedite product shipments through import/export requirements as required.
• Maintain knowledge and application skills of submission tools, internal databases, and codes within the scope of regulatory affairs.

Education:

• BS degree in a scientific discipline, preferably in the Life Sciences, Bio-medical, Mechanical engineering or the equivalent in education, training and experience.

Related Experience:

• Minimum of 0-3 years of Regulatory experience in medical device industry.

Special Competencies or Certifications:

• Regulatory Affairs Certification (RAC) a plus
• Knowledge of U.S. and International regulatory requirements for medical devices a plus
• Record of supporting project teams a plus
• Good Microsoft application skills
• Excellent written and oral communication skills
• Knowledge of current ISO 9001, ISO 13485, CMDR SOR/98-282, MDD 93/42/EEC, J-GMP and 21 CFR Part 820 a plus

Work Environment / Conditions:

• Ability to work together with others and in a team atmosphere; while displaying civility, cordiality, friendliness, empathy, etc.
• Ability to work in a fast-paced environment with varying amounts of individual responsibilities, conflict resolution, redirected priorities, etc.

At Dräger, it is our passion and dedication to protect, support and save lives. Our dedication to life naturally extends to the quality of our employees’ lives. They are the essence of our company, and without them, we would not be what we are today – a world leader in medical and safety technology. We are searching for people who want to join us in building “Technology for Life”.

Dräger has several sites located across North America as well as field-based sales and service positions. Our North America headquarters is located in Telford, PA just north of Philadelphia. We also have US sites in Andover, MA, and Houston, TX. Our Canada site is located in Mississauga.

Equal Opportunity Employer – Disability and Veteran

Benefits:

Dräger is responsible for life. The lives of our employees are especially important to us, therefore, Dräger provides a highly competitive and comprehensive benefits package. We invest boldly in a comprehensive benefits program – one that offers employees and their families a focus on wellness in addition to financial protection now and in the future.

• Health Insurance
• Flexible working time
• Professional development opportunities and coaching
• Health center and gym
• Company sports and prevention courses
• Contributions to (occupational) pension plans
• Retirement savings