Description

Acumed LLC


Position Title: Regulatory Affairs Specialist 3

Company: Acumed LLC

Req ID: JR0000038965


Location: Addison, TX

Time Type: Full time


Description:

Acumed LLC

As a part of the global industrial organization Marmon Holdings—which is backed by Berkshire Hathaway—you'll be doing things that matter, leading at every level, and winning a better way. We're committed to making a positive impact on the world, providing you with diverse learning and working opportunities, and fostering a culture where everyone's empowered to be their best.

Under general direction, responsible for leading the most complex activities associated with auditing. Participates in planning and conducting financial and operational audits, as well as leading/coaching other auditors. Role typically requires more than 5 years of experience.

Job Scope

The Regulatory Affairs (RA) Specialist is responsible for ensuring regulatory compliance for medical devices in accordance with applicable regulatory requirements (FDA, ISO, CE, etc.). The Regulatory Affairs Specialist will assist in regulatory submissions, listings, and registration of medical devices to comply with applicable regulatory standards dependent on functional RA scope (International, RA, Pre-Market and Strategy RA, Post-Market RA, etc.).

With increasing levels, the Regulatory Affairs Specialist will be expected to provide increasing leadership and mentoring along with more cross functional interaction both internally and externally.

Responsibilities

• Ownership of multiple programs within Regulatory Affairs.
• Technical lead and subject matter expert (SME) in change management activities, new product introduction, interactions with Regulatory Agencies, and submissions.
• Communicates effectively, has strong presentation skills, and influences key stakeholders.
• Coordinates tasks and risks identified amongst multiple projects with on-time delivery.
• Ability to operate within ambiguity, interpret regulatory requirements, and apply them strategically within Acumed's efforts.
• Ensures all processes for the essential regulatory affairs functions are documented and adhered to in procedures.
• Performs internal departmental audits and supports audits by third parties e.g., BSI, FDA and others, as required.
• Initiates and maintains required establishment listings e.g., FDA and EU, including renewal or changes.
• Develops company regulatory strategies and prioritization. Determines the best strategy to register new products in specific global markets.
• Determines appropriate product testing to support registration activities.
• Ensures content accuracy and regulatory compliance for submission to regulatory agencies e.g., 510(k), PMA, EU MDR Technical Files/Design Dossiers, global registration applications, etc.
• Provides feedback / approval of compliant labeling e.g., IFUs, marketing materials, package labels, etc.
• Manages and leads responses to Regulatory Agency for submission deficiencies.
• Maintains accurate international product registration, including renewal or changes, and certificates for foreign governments.
• Provides direction/guidance as needed to other Regulatory Specialists.
• Provides management with status updates on assigned responsibilities and goals and escalates issues in a timely manner.
• Mentors other Regulatory Affairs Specialists on regulation interpretation.
• Identifies changes in regulation and performs impact assessment.

Qualifications

• Bachelor's degree in engineering or science discipline.
• 7+ years of regulatory experience in the medical device industry (preferred 1-2 years of regulatory experience in orthopedics). Equivalent industry/educational experience may be considered.
• Subject Matter Expert in applied knowledge of applicable FDA, ISO, MDR requirements, consensus standards and guidance documents.
• Ability to work under limited supervision with FDA, Notified Body, EU Authorized Representative, and other global regulatory agencies.
• Able to manage multiple projects simultaneously.
• Proven track record of strong teamwork, creatively strategic thinking.
• Ability to work well with others, support regulatory activities and mentor/train others.
• Excellent written and verbal communication skills.
• Regulatory Affairs Certification (RAC) preferred.

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:


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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