The Job Responsibilities
- Manages and maintains worldwide country registrations and regulatory databases for DMSI 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.
BA/BS degree in business, engineering, medical or scientific discipline.
- 10+ years of regulatory experience in the Medical Device Industry. Experience in preparing and submitting Class II medical device marketing applications to regulatory agencies
Special Competencies or Certifications:
- Master’s degree in Regulatory Affairs and Quality Assurance or Regulatory Affairs Certification (RAC) a plus
- In depth knowledge of U.S. and International regulatory requirements for medical devices including ISO 9001, ISO 13485, EU MDD & MDR, J-GMP and 21 CFR part 820
- Project management experience a plus
- Internal/External Audit experience a plus
- Strong interpersonal, written and oral communication skills
- Strong computer skills and knowledge of databases
The Dräger Workplace
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.
Equal Opportunity Employer – Disability and Veteran
Who we are
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 ®
What we offer
Additional/Voluntary Insurance; Education & Training; Health center and gym; Health Insurance; Retirement Savings; Special Assistance; Time Away; Workplace Wellness