What are the responsibilities and job description for the Regulatory Affairs Senior Manager position at Intelliguard?

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 United States (US) and Canadian medical device regulatory requirements, specifically for Class I and Class II medical devices.

Have been the company's management representation to FDA and notified bodies.

Experience with international product registration (i.e. Canada, and Europe)

Ability to function in a controlled environment regulated by FDA QSRs and to handle confidential data.

Previous experience with IEC : 60601 and IEC : 62368 Standards and safety testing submissions.

Ability to meet deadlines; takes initiative and make decisions within department / company guidelines.

Analytical thinking and problem-solving skills and ability to follow-through.

Excellent communications skills, written and verbal.

Excellent interpersonal and negotiation skills and leadership potential.

Ability to work well independently and with others.

Excellent organizational skills and attention to detail.

Ability to handle multiple projects simultaneously and maintain flexibility.

Computer literate with excellent knowledge of systems for electronic storage and submission. Experience with Adobe Acrobat, MS Excel, MS PowerPoint, and MS Word, and ability to learn new computer programs.

Ability to meet deadlines; take initiative and make decisions within department / company guidelines.

Why You Should Join Us :

Generous Paid Time Off (Vacation, Sick, 10 Holidays, Floating Holiday Time)

Medical, Dental, Vision Plans

401K with Employer Match

Life / AD&D and Long-Term Disability (LTD)

Flexible Spending Account (FSA)

Voluntary Life / AD&D Optional Plans

Pet Plan

To play a part in helping hospitals and health systems continuously improve the environment of safety around every medication decision!

Other Information :

Onsite role in Columbus, OH (4 days onsite, 1 day remote)

Occasional travel, both nationally and internationally, may be required.

The essential functions of the job are usually performed in an office setting, in an indoor, temperature-controlled environment. The office environment noise level in the work environment is typically low to moderate. While performing the job duties, the employee is regularly required to sit for extended periods, standing and walking intermittently, reach with hands, arms, talk or hear. The employee is required to use office equipment such as a computer, mouse, keyboard, printer

The employee may sometimes be required to lift and / or move up to 35 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision and the ability to adjust focus.

We are committed to providing equal employment opportunities to all qualified individuals. If you require a reasonable accommodation to participate in the application or interview process, or to perform the essential functions of the job, we will work with you to provide an appropriate accommodation in accordance with applicable laws.

Relocation assistance is NOT available for this role.

The pay range for this role is :

140,000 - 167,000 USD per year (Ohio Office)

Salary : $140,000 - $167,000

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