Acumed is a global leader of innovative orthopaedic and medical solutions developed to improve patient care. With over three decades of experience in the orthopaedic industry, our mission is to aid the afflicted through the ingenuity of our minds, the labor of our hands and the compassion of our hearts. The company is headquartered in Hillsboro, Oregon with a global sales and distribution network supported by offices worldwide.
Regulatory Affairs Project Manager
The Regulatory Affairs Project Manager (RAPM) works with Regulatory and project team members to develop and execute registration plans for a global marketplace. S/he leads regulatory intelligence efforts for team members, helps ensures regulatory compliance of products and processes globally through management of department and interdepartmental process updates, and collects information to be provided in submissions. The RAPM provides Regulatory support for marketed products, (reviewing labeling, promotional materials, training materials, changes to existing devices and documentation). S/he trains and mentors regulatory team members and key personnel in emerging issues and changes in related procedures.
Develops and executes registration plans for a global marketplace, including evaluation of effects of regulatory, design, and manufacturing changes on plans and plan revision where appropriate.
Attends meetings and/or follows trade organizations and publications to stay aware of emerging issues.
Manages collection and distribution of regulatory intelligence through trade organization event attendance, review of available publications, interaction with regulatory bodies or distributors, and/or use of regulatory intelligence providers.
Assists in the development and maintenance of department procedures to ensure consistent, efficient and compliant regulatory processes.
Assists in the determination of appropriate testing requirements for registration or renewal of registration for Acumed product.
Ensures regulatory compliance of products and processes through management of or participation in department or interdepartmental process updates.
Facilitates short and long term planning by creating and maintaining Regulatory timelines and ensuring they are functional, consistent and integrated to reflect cross-functional dependencies.
Provides project team leadership as necessary.
Determines appropriate documentation required for various submissions (aligned with strategy) and coordinates with functional team members to obtain this information.
Conducts documentation reviews and change assessments, and determines required regulatory action (e.g. submissions, notifications).
Assists in development, organization, and application of labeling (e.g. instructions for use, marketing materials, package labels, etc.), and reviews and approves labelling and advertisement/promotional material to ensure regulatory compliance.
Leads or serves as regulatory representative in assigned projects or meetings to provide regulatory guidance to assure compliance with global regulatory requirements.
Trains and mentors key personnel on new or existing regulatory policies and processes as well as emerging issues identified above.
Bachelors of Science in science and/or engineering field. Advanced degree preferred.
5+ years of experience in medical device industry
5+ years of experience in regulatory affairs
Demonstrated experience preparing submissions (e.g. 510(k), technical file) and interacting with FDA, EU notified body and/or other regulatory agencies.
Experience with 21 CFR part 820, ISO 13485, EU Medical Device Regulation, and other applicable medical device regulations and standards (e.g. ISO 14971).
Experience with project management
Working knowledge of Acumed product
Demonstrates strong analytical, problem solving, and technical writing skills
Ability to work well with others, manage multiple projects simultaneously, and mentor/train others
Proven track record of strong team work and creative strategic thinking
Excellent written and verbal communication skills
Ability to read and speak English sufficiently to read, understand and complete all documentation
Regulatory Affairs Certification (RAC) preferred
PMP Certification highly preferred.
Internal Number: 799
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.