Analog Devices
Regulatory Affairs Specialist
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Regulatory Affairs Specialist
Regulatory Affairs Specialist – Digital Healthcare Group
About Analog Devices (ADI)
Analog Devices, Inc. (NASDAQ: ADI) is a global semiconductor leader that bridges the physical and digital worlds to power breakthroughs at the Intelligent Edge. ADI combines analog, digital, AI, and software technologies into solutions addressing climate change, human connectivity, healthcare, mobility, automation, energy, and data centers. In FY25, ADI achieved $11 billion+ in revenue, ensuring today’s innovators stay "Ahead of What’s Possible."
Summary of the Role
The Digital Healthcare Group at ADI is developing cutting-edge remote monitoring solutions that enhance patient care, quality of life, and cost efficiency. The team seeks a highly motivated Principal Regulatory Affairs Specialist to drive global compliance and regulatory strategy for new product development.
Specific Responsibilities
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Strategic & Technical Regulatory Guidance
- Provide expert input on regulatory requirements for novel technologies and product modifications, aligning with FDA and international standards.
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Regulatory Submissions & Documentation
- Author and lead pre-market submissions (Pre-Sub) and 510(k) submissions to support CE marking and international regulatory approvals.
- Draft technical documentation for compliance with global healthcare regulations.
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Regulatory Stakeholder Engagement
- Participate in negotiations and interactions with regulatory bodies (FDA, international agencies) during product review phases.
- Oversee international product registrations as needed.
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Project & Cross-Functional Collaboration
- Manage multiple projects, prioritizing tasks to meet deadlines.
- Collaborate with engineering, quality, clinical, regulatory, and marketing teams to ensure alignment.
- Review promotional and advertising materials for regulatory compliance.
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Compliance & Audits
- Maintain an up-to-date understanding of domestic and international healthcare regulations, guidelines, and standards (e.g., ISO 13485, MDSAP).
- Update/develop departmental regulatory procedures to reflect evolving standards.
- Act as a lead for internal/third-party audits (e.g., FDA, MDSAP facilities audits).
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Regulatory Documentation & Training
- Ensure comprehensive Regulatory Affairs documentation supports compliance with ISO 13485 and 21 CFR 820.
- Train employees on Quality Management System (QMS) processes.
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Miscelaneous Duties
- Execute other duties as required by the business.
Requirements
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Education & Skills
- Master’s degree in Regulatory Affairs (or related field).
- Hands-on experience with:
- ISO 13485 (Medical Devices)
- MDSAP (Medical Device Single Audit Program)
- FDA QSR compliance
- Willingness to problem-solve without hesitation—"no task is too hands-on."
- Demonstrated ability to learn quickly and adapt to evolving regulations.
Export Control Note
Positions requiring access to technical data may require export licensing approval from:
- U.S. Department of Commerce – BIS
- U.S. Department of State – DDTC
Applicants (except U.S. citizens, permanent residents, and protected individuals), may undergo additional review.
Company Commitment
Analog Devices is an equal opportunity employer, committed to fostering a culture where everyone thrives regardless of: Race, color, religion, age, ancestry, national origin, ethnicity, sex, sexual orientation, gender, gender identity, expression, marital status, pregnancy, parental status, disability, medical condition, genetic information, military/veteran status, union membership, or political affiliation.
Job Details
- Job Type: Experienced Hire
- Travel Requirement: Up to 10% of time
- Shift: First Shift / Daytime
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