Job 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 Specialist 2, Business Development is responsible for regulatory activities associated with inorganic growth channels such as acquisitions, new product outsourcing, and distribution agreements. This role develops and maintains processes to accelerate business development opportunities, while ensuring compliance with all regulatory requirements. This role also leads strategic Regulatory Affairs initiatives as determined by strategic planning and annual goal setting.

Responsibilities

• Maintains working knowledge of medical device regulations applicable to devices being supported including, but not limited to, registration, classification, labeling, and post-market surveillance requirement through on-going education and training.
• Owns Quality/Regulatory processes and develops procedures, templates, and tools related to acquisitions, integrations, outsourcing, distribution agreements and other inorganic growth opportunities.
• Performs due diligence on target opportunities to confirm accuracy of data and identify any quality risks.
• Identifies mitigation plans for key risks or major findings and addresses in the integration plan.
• Serves as functional lead for Regulatory on outsourced development projects.
• Prepares, organizes, and coordinates data for submission to and manages correspondence with regulatory and standards agencies or organizations.
• Supports internal and external audits.
• 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. Provides feedback advertisement/promotional material to ensure regulatory compliance.
• Reviews and disposition ECRs/ECOs for potential impact to new and existing registrations. Converts and/or approves ECRs/ECOs requiring regulatory review.
• Reviews and approves test protocols and test reports necessary to support market registrations.
• Prepares and ensures content accuracy for submission to regulatory agencies e.g., 510(k), PMA, vigilance reports, MDR Technical Files/Design Dossiers, global registration applications, etc.
• Provides regulatory training for lower-level personnel.

Qualifications

• Bachelor of Science with 2-5 years of regulatory experience or 6-8 years’ experience in medical device industry
• Thorough working knowledge of applicable FDA, ISO, MDR requirements, consensus standards and guidance documents
• Ability to represent and provide regulatory support in audits/inspections, product development, sustaining activities, and other activities as directed
• Experience in communications and submissions with regulatory authorities including 510(K)s, product registrations, change notifications, field actions/recalls
• Excellent written/verbal communication skills
• Ability to read/speak English sufficiently to read, understand and complete all documentation
• Exceptional organizational skills with extensive knowledge of MS Office
• Knowledge and experience with ERP systems, SAP 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.

Job Tags

Similar Jobs