• Leads the development and internal review of regulatory strategies and ensures that registration documentation for development projects are appropriately submitted in alignment with timeline expectations. This is achieved by;

• evaluating the regulatory environment throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) and

• helping to train stakeholders on current and new regulatory requirements to ensure product compliance

• Manages and maintains worldwide country registrations and regulatory databases for SPP product portfolio. Reviews US and international standards and regulations for applicability to the Draeger product portfolio.
• Determines and communicates requirements and options for regulatory submissions, approval pathways, and compliance activities, and provides regulatory support and guidance throughout the product lifecycle.
• Prepares, updates and maintains product regulatory submissions (510(k), Technical Files, Canadian Licenses and International registrations).
• Drives RA focused projects and acts as project lead where required. Develops and/or improves development processes, procedures and protocols that assist in meeting internal SOP’s, FDA and industry regulations.
• Participates in cross functional teams providing recommendations and guidance to ensure products meet regulatory requirements. Creates/approves assigned Regulatory deliverables for projects/packages.
• Evaluates impact of product changes to regulatory submissions worldwide, documenting regulatory decisions and communication/actions required for impacted regions.
• Manages requests from regions and countries, provides responses and requested documentation (CFG’s, certifications, document legalization, etc.) in a timely manner.
• Collaborates with parties such as EU notified body officials, consultants, and government agencies including the FDA in support of product approvals and audits.
• Reviews, approves and provides guidance for labeling and advertising. Ensure proper facility registrations and device listings for DMSI with appropriate regulatory agencies.
• Performs other duties as needed and assigned

Education:

BS degree in a scientific discipline, preferably in the Life Science, Biomedical, Mechanical engineering or the equivalent in education, training and experience.

Experience:

• 8-12 years of regulatory experience in the Medical Device Industry is required. Experience in preparing and submitting Class II medical device marketing applications to regulatory agencies

Special Competencies or Certifications:

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

In North America, Draeger employees over 1,400 employees working in our major sites in the United States and Canada (in the US: Andover, MA; Telford, PA; Houston / Coppell, TX, and in Canada: Mississauga, ON), including our Sales and Service workforce employees from coast to coast.

Our US headquarters located north of Philadelphia in Telford, Pennsylvania is our US manufacturing site for our Neonatal product line supplying many global customers as well as production support for Draeger’s Safety products. This location also serves as the key site for essential US functions which includes Medical Sales and Service Management, Medical Marketing, Legal, Compliance, Regulatory, Quality and Finance.

Due to the nature of this position, qualified candidates will be required to be fully vaccinated for Covid-19. Proof of vaccination will be required as part of the onboarding process. You may be required to carry your vaccination card when on-site at client customers.

Equal Opportunity Employer – Disability and Veteran

Draeger is a leading international company in the fields of medical and safety technology. Whether in clinical applications, in industry, mining or emergency services: Draeger products protect, support and save lives. That's what our more than 15,000 employees have been striving for - every day for more than 130 years. Dräger - Technology for Life ®

• Additional/Voluntary Insurance
• Workplace Wellness
• Special Assistance
• Health Insurance
• Education & Training
• Health center and gym
• Time Away
• Retirement Savings