Regulatory Compliance Engineer II

Education & Qualifications

• Bachelor's degree in Engineering, Regulatory Affairs, Life Sciences, Chemistry, Physics, or a related technical discipline required.
• Minimum 5 years of experience in regulatory compliance, product compliance, quality systems, or a related field.
• Experience within life sciences, biopharmaceutical, medical device, diagnostics, analytical instrumentation, or other highly regulated industries preferred.
• Working knowledge of global product compliance and regulatory requirements such as EMC, PED, RoHS, REACH, PFAS, Cal Prop 65, Low Voltage Directive, Machine Directive, or similar standards.
• Experience interpreting technical regulations, customer requirements, and industry standards and translating them into business processes and compliance actions.
• Familiarity with 21 CFR Part 11, Annex 11, USP, EP, EDQM, JP, or comparable pharmaceutical and life sciences standards preferred.
• Experience coordinating external testing, certification, validation, or regulatory assessment activities is highly desirable.
• Strong analytical, problem-solving, and organizational skills with exceptional attention to detail.
• Experience working with ERP systems such as SAP and document management platforms, including SharePoint.
• Proven ability to build strong partnerships and effectively influence cross-functional stakeholders.
• Excellent written and verbal communication skills.
• Demonstrated ability to manage multiple priorities, adapt to changing requirements, and drive results in a fast-paced, growth-oriented environment.
• Our mission is to inspire advances in bioprocessing as a trusted partner in the production of biologic drugs that improve human health worldwide. Focused on cost and process efficiencies, we deliver innovative technologies and solutions that help set new standards in bioprocessing. The estimated base salary range for this role, based in the United States of America is $85,000-$125,000. Compensation decisions are dependent on several factors including, but not limited to an individual's ,qualifications, location, internal equity, and alignment with market data. Additionally, employees are eligible to participate in one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits such as paid time off, health/dental/vision, retirement benefits and flexible spending accounts. All compensation and benefits information will be confirmed in writing at the time of offer.