European Union Regulatory Affairs, Medical Device, Quality/Risk Management, Submission & Registration
The Regulatory Specialist helps create, develop and maintain materials needed for regulatory compliance. Assists with company compliance activities, new product submissions, listings, and registration of medical devices. Works independently as necessary.
Understands regulations, follows complex directions, and investigates when clarification is needed.
Initiates International product registration, including renewals or changes and certificates for foreign governments.
Manages correspondence with the regulatory and standards agencies or organizations such as FDA, MDD Notified Body, Health Canada, Medimark.
Prepares, organizes, and coordinates data for submission to the FDA or regulatory agencies (e.g. 510(k), MDD Technical Files, etc.).
Participates in the preparation and execution of ISO and FDA audits.
Assures regulatory compliance and content accuracy of Technical Files and 510(k) files.
Completes the duties described in the Quality Manual.
Assists in package insert (instructions for use) development, organization and application.
Assists in determination of appropriate safety, regulatory, evaluation and testing requirements for new and approved products.
Product development design review team and risk team contributor, providing regulatory/compliance perspective and expertise, to assure products are in compliance with relevant US and foreign standards, codes and regulations.
Reports standards changes and summarizes impact on Acumed products.
Involvement in new country/market registration as required.
Assists in labeling (e.g. package inserts/IFUs(instructions for use), marketing materials, package labels, etc.) development, organization, application and/or review.
Assists in development of company regulatory strategies and determine priorities with Sales & Marketing, Engineering and Quality.
Reports standards changes, determines impact and takes appropriate action.
Provides regulatory training to lower level regulatory personnel.
Bachelor of Science in Biology, Chemistry or related field required.
Thorough working knowledge of applicable FDA, CMDCAS, ISO, and MDD requirements and consensus standards.
3 - 5 years of regulatory experience or 5+ years of experience in the medical device or equivalent industry (quality or orthopedic engineering).
Ability to support and execute activities related to product development teams and projects.
Ability to work well with others and manage projects.
Excellent written and verbal communication skills.
Ability to read and speak English sufficiently to read, understand and complete all documentation.
Internal Number: 624
A Company Built on Ingenuity, Hard Work, and Compassion
What started as a small family business in 1988 has since evolved into a global market leader, providing orthopaedic and medical solutions that improve patient care around the world.
The Acumed story begins in Butler, NJ, where Mary and Randy Huebner founded Accurate Machine and Design, also known as Acumed. With only one machinist on staff, Acumed was contracted to engineer implant prototypes for some of the biggest names in the industry.
After relocating to Oregon in 1991, we launched our first line of arthroscopy screws intended for ACL ligaments and haven’t looked back since. The successes of the Oregon Fixation Screw allowed Acumed to research, design, and manufacture the majority of our products while adding new lines each year. In 1999, Acumed became a member of The Marmon Group and subsequently, in 2002, a member of the Colson Associates group of companies.
Headquartered in Hillsboro, Oregon, with a global distribution network and offices worldwide, Acumed is a multi-award-winning company dedicated to innovative and quality medical device solutions. We are committed to the highest standards of manufacturing... and proudly produce over 90% of our implants in the U.S.
Throughout our history, Acumed has remained focused on the founders’ original vision of providing innovative solutions to meet the needs of the whole healthcare community, including hospitals, surgeons, and patients.