Regulatory Compliance Engineer II (Life Sciences)

Location: Remote - Massachusetts, United States

Salary: $85,000–$125,000 per year, plus eligibility for variable cash programs and, where applicable, equity.

Company

hirify.global develops technologies and solutions for bioprocessing and the production of biologic drugs.

What you will do

• Support product compliance activities across hardware, automation, chromatography, and protein business units.
• Interpret legal requirements, technical regulations, customer specifications, and industry standards, translating them into compliance processes and actions.
• Maintain compliance documentation for products and raw materials, including RoHS certifications, REACH declarations, Safety Data Sheets, and regulatory records.
• Coordinate external testing, certification, validation, and regulatory assessment activities with laboratories and third-party organizations.
• Partner with engineering, quality, sourcing, R&D, EH&S, support, applications, and knowledge-management teams to identify gaps and implement solutions.
• Support product design, root-cause investigations, corrective actions, quality agreements, URS reviews, and regulatory requirements matrices.

Requirements

• Bachelor’s degree in engineering, regulatory affairs, life sciences, chemistry, physics, or a related technical discipline.
• At least 5 years of experience in regulatory compliance, product compliance, quality systems, or a related field.
• Working knowledge of EMC, Pressure Equipment Directive, RoHS, REACH, PFAS, California Proposition 65, Low Voltage Directive, Machine Directive, or similar requirements.
• Experience interpreting technical regulations and customer requirements and converting them into business processes and compliance actions.
• Experience with ERP systems such as SAP and document-management platforms such as SharePoint.
• Strong analytical, problem-solving, organizational, communication, stakeholder-management, and prioritization skills.

Nice to have

• Experience in life sciences, biopharmaceuticals, medical devices, diagnostics, analytical instrumentation, or another highly regulated industry.
• Familiarity with 21 CFR Part 11, Annex 11, USP, EP, EDQM, JP, or comparable pharmaceutical standards.
• Experience coordinating external testing, certification, validation, or regulatory assessment activities.

Culture & Benefits

• Collaborative work with engineering, quality, sourcing, R&D, and other cross-functional teams.
• Paid time off and health, dental, and vision benefits.
• Retirement benefits and flexible spending accounts.
• Eligibility for variable cash programs and equity for applicable roles.
• Work focused on bioprocessing technologies that support biologic drug production.