Regulatory Affairs Senior Manager

About Intelliguard:

Intelliguard protects patients and hospitals by creating a continuously improving environment of safety around every medication decision through an advanced data platform, interoperable software architecture, and RFID-powered station and cabinets. Ours is a global, data-first company that delivers clinical, supply chain, and regulatory solutions to ensure safety and positive outcomes from supplier to patient.

We continue to expand our product lines and deploy groundbreaking solutions that enable safety across the healthcare supply chain. Join our team of engineers, developers, pharmacy professionals, quality control experts, and commercial team associates as we drive toward breakthroughs every day.

Ours is a history we’re proud of. And our future is one we look forward to. Come join us!

About The Role:

Intelliguard has an excellent opportunity for a Regulatory Affairs (RA) Senior Manager to join our team in Columbus, OH, reporting to the Senior Director of Operations. As an RA Senior Manager, you will be responsible for helping to ensure the company successfully meets all compliance requirements while achieving critical deadlines for key regulatory demands. This includes the management and preparation of various critical regulatory documents such as: product Safety Data Sheets, product labels, product attestation documents and certifications. This role will handle multiple types of documentation requests from internal and external customers as well as conduct research regarding various critical documents, certifications, and permits for the company.

What You'll Be Doing:

• Ensures planned medical device development activities comply with United States (US) and potentially out of United States (OUS) regulatory guidelines.
• Has recognized regulatory expertise related to labeling and packaging requirements to ensure accuracy and compliance with regulations and aligned with the commercial needs. This role will maintain UDI and GUDID requirements.
• Maintain Intelliguard’s regulatory registrations, which include, but are not limited to FDA, CDPH, Health Canada, Intertek, NEMKO, and SGS.
• Plans and prepares complex regulatory documents for United States (US) and potentially out of United States (OUS) submissions. (Canada, EU)
• Critically reviews complex reports, validations, etc. for scientific merit and regulatory appropriateness.
• Represents Regulatory in project teams. Provides regulatory strategy and develops regulatory filing strategy, where applicable.
• Works collaboratively with Operations/Product/Quality/Executive team/Software team to resolve complex project issues.
• Prepares clear, complete, and accurate documents that are logically constructed and comprehensive in content and on time.
• Maintains professional relationships with functional areas outside regulatory.
• Develop professional relationships with Health Authorities and/or regulatory agencies.
• Assists in training and mentoring of personnel and perform peer review of documents.
• Support the review and approval of product labeling, promotion and advertising materials as needed.
• Support regulatory impact assessments for change controls and other RA/QA items from a review and approve level.
• Assess regulatory pathways for new products and product modifications; develops regulatory strategies plans for submissions.
• Perform other duties as assigned.

We Would Love To Hear From You, If:

• Minimum 10 years of directly related Regulatory Affairs experience in medical devices.
• Bachelor’s degree of Science or Engineering with considerable experience in QA/RA positions in a similar regulated medical industry.
• Proven expertise in regulatory approval processes for hardware and software as a medical device (SAMD).
• Experience with regulatory compliance for 21CFR 820, ISO:13485, EU Medical Device Regulation (EU MDR), IEC:62034, and ISO:14971.
• Demonstrated experience of submissions to FDA as a primary contact and lead meetings with FDA
• Has recognized regulatory expertise and knowledge of regulatory requirements with ability to strategically interpret and communicate requirements. At a minimum, this role shall have regulatory expertise regarding U