JOB DESCRIPTION SUMMARY

Reporting to Medication Management Systems (MMS) Pharmacy Automation (PA) team, the Staff Specialist of Regulatory Affairs provides regulatory expertise to MMS-PA platform. This individual facilitates the regulatory affairs activities within the MMS-PA platform. He/she contributes to the development of MMS-RA strategic and operational plans through sound assessments of regulatory pathways and risks, and sound regulatory programs. Such assessments may influence the scientific or technical direction of product design and/or development in support of worldwide registrations. The Staff Specialist of Regulatory Affairs will ensure functional excellence in regulatory activities to achieve timely worldwide clearance, approval, registration, and licensure of MMS-PA products with desired claims. This individual will help communicate new developments in worldwide regulations affecting MMS-PA products to MMS-PA stakeholders.
We provide flexibility at the workplace! This position can be filled as full-time and part-time as well.

QUALIFICATIONS:

• Proven ability to perform advanced critical thinking, exercise independent judgment, and operate effectively within broad policies and practices.
• Track record of delivering innovative solutions to achieve business objectives, with strong business acumen and problem-solving skills.
• Exceptional communication (oral and written), negotiation, and interpersonal skills; adept at collaborating in cross-functional, regional, and matrixed team environments.
• Strong prioritization, organizational, and planning abilities with a detail-oriented approach, focused on accuracy, completeness, and timely results.
• Demonstrated ability to handle ambiguity, assess potential problems, and implement effective corrective actions to prevent recurrence.
• Experience as a change agent, driving continuous improvement initiatives and fostering adaptability in dynamic, fast-paced settings.
• Background in project management, continuous improvement, product development processes, and design control methodologies.

EDUCATION AND EXPERIENCE:

• B.A. or B.S. degree required with a focus in health science or life science field (biology, microbiology, chemistry, engineering, medical technology, etc.) preferred.
• MS degree in health science, regulatory affairs, or applicable discipline a plus.
• RAC/RCC Certification a plus.
• Minimum of 5 years directly applicable regulatory affairs work experience (e.g., IVD 510(k), PMA, de novo, IVDD and IVDR compliant tech files, etc.) required with experience in a medical device company preferred. Electrical equipment related experience/knowledge is preferred.
  Click on apply if this sounds like you!
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  Required Skills
  Optional Skills
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• Provide pre-market regulatory expertise and facilitate regulatory affairs activities within MMS-PA.
• Develop and execute pre- and post-market regulatory strategies aligned with local, national, and international requirements.
• Prepare and manage regulatory submissions, including EU Technical Files for CE marking and global product registration materials.
• Act as a regulatory advisor in product development, ensuring compliance with standards, claims development, labeling, and promotional materials.
• Collaborate with Quality functions to address compliance activities and audit findings, supporting inspections by regulatory bodies.
• Monitor and communicate global regulatory developments, assess risks, and influence strategic and operational planning.
• Drive functional excellence by improving regulatory capabilities, fostering continuous improvement, and ensuring team engagement and efficiency.