Regulatory Affairs Specialist 1 at Acumed LLC in Hillsboro, Oregon

Job Description:

Acumed LLC


Position Title: Regulatory Affairs Specialist 1

Company: Acumed LLC

Reg ID: JR0000030044

Location: Hillsboro, OR
Addison, TX

Time Type: Full time


Description:

Acumed LLC

Come join a team where People make the difference! As a part of Marmon Holdings, Inc., a highly decentralized organization, we rely heavily on people with the aptitude, attitude, and entrepreneurial spirit to drive our success, and we're committed to attracting and retaining top talent.

Job Scope

The Regulatory Affairs Specialist 1 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.

Responsibilities

• Understands regulations, follows complex directions, and investigates when clarification is needed.
• Develops a working knowledge of the medical device regulations applicable to the devices being supported including, but not limited to, registration, classification, labeling, and post-market surveillance requirements.
• Reports relevant regulation and standard changes and assists in determining impact and appropriate action. Ensures regulatory compliance of products and processes through participation in process updates.
• Assists in determination of appropriate safety, regulatory, evaluation and testing requirements for new and approved products.
• Works with team members to conduct documentation reviews and change assessments including evaluation of effects of regulatory, design, and manufacturing changes, and helps determine required regulatory action e.g., submissions, notifications.
• Assists in preparing, organizing, and coordinating data for submission to and manages correspondence with the regulatory and standards agencies or organizations such as FDA, EU Notified Body, Health Canada, EU Authorized Representative, and Third-Party License Holders.
• Manages correspondence with regulatory and standards agencies or organizations such as FDA, Notified Body, Health Canada, ISO, Acumed’s EU Authorized Representative.
• Supports internal and external (third party) audits as required.
• Assists in development, organization, and application of labeling e.g., instructions for use (IFU), package labels, etc. Initiates updates to labeling to ensure compliance with registrations.
• Attends meetings and/or follows trade organizations and publications to develop understanding of requirements in assigned markets.
• All other duties as assigned.

Qualifications

• Bachelor of Science in biology, chemistry, engineering, or similar degree with 1 year of regulatory experience or 5-6 years’ experience in the medical device industry e.g., quality, regulatory, or engineering. Equivalent industry/educational experience may be considered.
• Knowledge of applicable FDA, ISO, MDR requirements, consensus standards and guidance documents.
• Ability to support regulatory activities, as directed.
• Ability to work well with others.
• Excellent written and verbal communication skills.
• Ability to read and speak English sufficiently to read, understand and complete all documentation.
• Exceptional organizational skills with extensive knowledge of MS Office i.e., Excel, Word, Outlook.

Following receipt of a conditional offer of employment, candidates will be required to complete additional job-related screening processes as permitted or required by applicable law.

We are an equal opportunity employer, and all applicants will be considered for employment without attention to their membership in any protected class. If you require any reasonable accommodation to complete your application or any part of the recruiting process, please email your request to careers@marmon.com, and please be sure to include the title and the location of the position for which you are applying.

About Us:

With more than 100 autonomous manufacturing and service businesses, Marmon Holdings, Inc. may be the biggest company you’ve never heard of. Part of Berkshire Hathaway Inc., Marmon is a global industrial organization comprising 11 diverse groups with 20,000-plus employees and $10 billion in annual revenue.

As leaders in every industry we serve, Marmon companies have earned a great degree of independence. And our people thrive on an entrepreneurial spirit. At the same time, our group structure gives every Marmon company access to the expertise of other Marmon companies serving the same or related markets and customers – all with the support of the entire Marmon organization.

Working together, we become something more than the sum of our parts. We become the most reliable solution provider for a broad range of industries and customers worldwide.

In every case, Marmon’s success is due to our people. People with talent, drive and high ethical standards. People who are following their passions and building their careers across Marmon.

Want to learn and perfect your craft? Want to sharpen your skills while helping to solve challenges for our customers and our world? Looking for a chance to grow within – or perhaps outside – your field? Find a Marmon company that matches your passion. And see what you can do with the support of a team that values your contribution.

Acumed is an equal opportunity employer. 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.

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