Regulatory Associate at Acumed in Hillsboro, Oregon
Posted in General Business 30+ days ago.
Type: Full-Time
Job Description:
About Us
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 Associate
The Regulatory Associate supports the overall regulatory function by helping to maintain regulatory processes and systems. S/he utilizes computer and software proficiencies to create, coordinate, procure and/or maintain data and documentation to support US and OUS medical device registration. The Regulatory Associate also employs an attention to detail and developing familiarity with products and processes to ensure databases, dashboards and documents are current and correct.
Duties/Responsibilities
- Enters registration data into database and dashboard. Audits registration data in applicable systems to ensure data is current and correct.
- Coordinates requests from regulatory team and procures requested items such as document translation, notarization, and/or legalization; standards; journal articles; CFGs (Certificate to Foreign Government) and FSCs (Free Sale Certificates).
- Coordinates document changes to regulatory-owned documents within document control systems and ensures documents are stored per procedure, including registration submissions and correspondence with regulatory bodies.
- Prepares and publishes IFUs (Instructions for Use) or other related documents following procedure and with input from senior level team members.
- Completes data searches and provides compiled data (e.g. for clinical evaluation) to regulatory team.
- Works with team members to prepare documents for registration submissions (e.g. consolidation of multiple documents into a single document, bookmarking relevant sections, preparation for e-submission).
- Provide other administrative regulatory support as needed.
Qualifications
- Bachelor's degree in science, health or technical discipline. Relevant experience may be considered in lieu of educational background.
- 0 - 2 years of medical device regulatory experience.
- Computer/technical proficiency including experience with MS Office and working knowledge of Adobe, InDesign, SAP, WindChill and other software as needed
- Preferred knowledge of applicable US, EU and/or other region-specific medical device regulations, requirements and standards.
- Experience with quality and document control systems in a regulated space preferred.
- Ability to work well with others, manage multiple projects simultaneously, and follow directions.
- Excellent attention to detail and verbal and written communication skills.
- Ability to read and speak English sufficiently to read, understand and complete all documentation.
Acumed and ACUTE are equal opportunity employers. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with a disability.
As an equal opportunity employer, Acumed is committed to providing reasonable accommodations to applicants with disabilities. If you are interested in applying to Acumed and need special assistance or accommodation, please contact us at recruiting@acumed.net .
Acumed https://acumed.applicantpro.com
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