About Careertakes

👉 Important disclosure: Careertakes is a third-party recruiting platform supporting this hiring process. If selected, you will be employed directly by our client, Scientific & QA.

Applicants for this role may also receive access to additional matched opportunities through the Careertakes platform.

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Key Responsibilities

• Assist in preparation and maintenance of regulatory submissions and product registrations for medical devices.
• Maintain regulatory files, databases, and documentation for global registrations.
• Support change control and quality system documentation aligned with ISO 13485/MDSAP practices.
• Provide administrative support during audits and inspections.
• Coordinate physical document legalization and work with outside agencies to complete international registration requirements.
• Collaborate with cross-functional teams (R&D, Manufacturing, Marketing) to ensure regulatory strategy throughout the product lifecycle.
• Help define and implement regulatory department processes that support design & development, manufacturing, distribution, and market release.
• Support continuous improvement of regulatory aspects of the Quality System; update procedures when regulatory requirements change.
• Serve as a regulatory representative on assigned projects and help execute go-to-market regulatory activities.

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Qualifications

• 0–2 years of regulatory affairs experience, preferably in medical devices (respiratory/anesthesia a plus).
• Bachelor’s degree in Regulatory Affairs, engineering, life sciences, or equivalent industry experience.
• Basic knowledge of medical device regulations (FDA 21 CFR) and global requirements including EU MDD/MDR.
• Familiarity with standards such as ISO 14971 and ISO 13485/MDSAP preferred.
• Strong organizational skills, attention to detail, and the ability to manage multiple priorities and deadlines.
• Effective written and verbal communication skills.
• Proficient with Microsoft Office; experience with regulatory submission timelines and project deliverables is preferred.

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Travel & Location

• Local travel required to complete physical document legalization and occasional site visits, as business needs dictate.
• This role is based in Comstock Park, MI (Comstock Park, Michigan). Applicants must be eligible to work in the United States.

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Other Responsibilities & Expectations

• Uphold and embody Confidential Client’s values and company policies.
• Demonstrate accuracy, thoroughness, and a focus on quality and safety.
• Contribute positively to team environment and cross-functional collaboration.
• Be adaptable; responsibilities may evolve with business needs.

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Benefits

• Medical, dental, and vision coverage (subject to eligibility).
• 401(k) plan.
• Paid time off and paid holidays.
• Employee assistance resources and medical leave benefits.
• Certain roles may be eligible for bonuses or other incentive compensation.

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Quality & DEIA Statements

• Quality: Confidential Client maintains a continuously improving Quality Management System and is committed to regulatory compliance and product excellence.
• Diversity, Equity, Inclusion & Advancement (DEIA): Confidential Client is committed to building a diverse, inclusive workforce and an equitable workplace that reflects the communities served.

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Equal Opportunity & Hiring Transparency

Careertakes and our client are Equal Opportunity Employers committed to building a diverse and inclusive workforce. We prohibit discrimination or harassment of any kind. To support a fair and efficient hiring process, AI tools may be used to assist with application review or resume screening. These tools do not replace human decision-making. Final hiring decisions are made by people.

If you have questions about how your data is used, please contact us directly.