Regulatory Affairs Specialist I - Kitting

At Owens & Minor, we are a critical part of the healthcare process. As a Fortune 500 company with 350 facilities across the US and 22,000 teammates in over 90 countries, we provide integrated technologies, products and services across the full continuum of care. Customers—and their patients—are at the heart of what we do.

Our mission is to empower our customers to advance healthcare, and our success starts with our teammates.

Owens & Minor teammate benefits include:

• Medical, dental, and vision insurance, available on first working day

• 401(k), eligibility after one year of service

• Employee stock purchase plan

• Tuition reimbursement

Job Summary

The Regulatory Affairs Specialist I assists in the development and implementation of regulatory strategies to support the achievement of business objectives while coordinating activities with internal team members and external parties such as regulatory bodies, regulatory consultants and the like to obtain and maintain regulatory filings, registrations and compliance.

The Regulatory Affairs Specialist I reports to the Manager of Regulatory Affairs for the CPT (Custom Procedure Trays) product line. The individual is responsible for monitoring design controls, evaluation of components, labeling review and compliance, Copy & Claims review, and change control processes to assure policies, procedures and practices are followed and in compliance with appropriate regulatory requirements. This individual provides analytical, interpretive and evaluative solutions to complex problems through specialized regulatory expertise based on an in-depth knowledge of technical and business practices. The incumbent integrates and coordinate activities within clearly defined policies; helps develop and champion regulatory policies; relies on an ability to understand and motivate people without direct authority. Position is responsible for directing and coordinating activities necessary to ensure global regulatory compliance with FDA, Canadian, European and other agency regulations, where applicable. This position will assist with division regulatory activities, including communicating with regulatory agencies, as well as with other internal functional departments for new product development strategy. This position also oversees existing division products and submits requests for changes to licenses, registrations, and device listings.

Core Responsibilities

• Assists the contracts and sales team during new products development as well as assists in design control processes

• Assists with compiling component and finished good attributes to support import/export requirements.

• Reviews Copy & Claims requests for compliance to internal procedures and requirements.

• Reviews labeling for compliance to procedures and FDA requirements.

• Assists with determining regulatory strategies and completing regulatory assessments

• Submits required documentation to Health Canada for changes to establishment and device licenses

• Reviews and makes final determinations for regulatory assessments of proposed changes to existing products

• Reviews and approves new components, new finished goods, and associated changes, for compliance to company procedures and regulations.

• Reads, reviews, interprets and keeps current with regulations and publications regarding

• convenience kitting, including drugs, cosmetics, and medical device products
• Assists with the management of company regulation and documentation programs including development and distribution of standard operating procedures (SOPs), policies, and technical reports, where applicable
• Participation and support for all continuous improvement and SOP efforts which leads to increased productivity, profitability, and customer satisfaction in areas of responsibility
• Provides assistance to contracts and sales teams with regards to product registration status and product characteristics needs for customer contracts
• Coordinates recalls, communications, and FDA reporting for the CPT business.

Qualifying Experience

• Bachelor’s degree in biological sciences, microbiology chemistry or engineering required; Graduate studies in Regulatory Affairs strongly preferred

• RAC certified professional and project management skills desirable

• 3 years’ experience in Regulatory Affairs, preferably in a medical device company

• Experience in communicating with FDA, Notified Bodies and other regulatory agencies

• Working knowledge of ISO and applicable International regulations, compliance and audit practices

• Intermediate level proficiency in Microsoft Office programs (Excel, PowerPoint, Word)

• Prudent and practical decision-making abilities, a team player, and can work independently without direct supervision

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If you feel this opportunity could be the next step in your career, we encourage you to apply. This position will accept applications on an ongoing basis.

Owens & Minor is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, sex, sexual orientation, genetic information, religion, disability, age, status as a veteran, or any other status prohibited by applicable national, federal, state or local law.