Regulatory Affairs Coordinator

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Assist in Quality and Regulatory Affairs intelligence initiatives by tracking new and evolving regulations, standards, and regulatory guidance.

• Manage the organization's Standards e-system, standards watchlists, inventory of applicable standards, regulatory intelligence documentation, trackers, and supporting materials.

• Oversee the Regulatory Change Notification process for modifications impacting registrations, licenses, certifications, technical documentation, labeling, or regulatory obligations.

• Maintain regulatory correspondence and related records.

• Act as the QARA subject matter expert for FDA Automated Commercial Environment (ACE) and FDA/CBP medical device import regulations.

• Coordinate and uphold FDA ACE data for imported finished products, components, raw materials, and other regulated items.

• Assist in the creation, review, and upkeep of FDA-related master data in SAP ECC6, SAP MDG, or other enterprise systems.

• Collaborate with Trade Compliance, Supply Chain, Logistics, Customs Brokers, and Regulatory Affairs to ensure compliant import activities.

• Aid in resolving FDA/CBP import-entry challenges, including FDA Notices of Action, entry holds, detentions, document requests, and other inquiries.

• Monitor modifications to FDA/CBP import requirements and facilitate assessment and implementation.

• Serve as an administrative liaison for Notified Bodies and regulatory authorities.

• Track regulatory commitments, information requests, audit actions, and necessary responses.

• Support regulatory inspections, assessments, and Notified Body audits.

• Maintain regulatory trackers, databases, certificates, licenses, registrations, and relevant documentation.

• Assist in the preparation, compilation, formatting, and administrative processing of regulatory submissions and notifications.

• Prepare regular regulatory status reports and metrics.

• Escalate complex regulatory strategies, legal interpretations, significant commitments, reportability decisions, and novel or high-risk import issues.

⛳️ Requirements

• Bachelor's degree in Regulatory Affairs, Life Sciences, Engineering, Quality, Supply Chain, Business, or a related field is preferred.

• 3–5 years of experience in Regulatory Affairs, Regulatory Operations, Quality, Trade Compliance, or a similar medical device environment.

• Strongly preferred experience with FDA ACE requirements and medical device importation.

• Knowledge of FDA medical device establishment registration, device listing, product codes, and import-entry requirements.

• Familiarity with U.S. Customs and Border Protection (CBP) processes and working alongside customs brokers.

• Understanding of ISO 13485, FDA medical device requirements, and EU MDR.

• Preferred experience with regulatory intelligence or standards-management systems.

• Excellent organizational, analytical, and project coordination abilities.

• High attention to detail and capacity to manage multiple regulatory deadlines effectively.

• Strong written and verbal communication skills.

• Knowledge of regulatory intelligence and standards monitoring.

• Understanding of regulatory change coordination.

• Familiarity with FDA ACE and medical device import compliance.

• Knowledge of FDA/CBP regulatory requirements.

• Awareness of regulatory authority and Notified Body coordination.

• Expected travel up to 10%.

🏝️ Benefits

• Medical insurance.

• Prescription drug insurance.

• Dental insurance.

• Vision insurance.

• Flexible spending accounts.

• Participation in a 401(k) savings plan.

• Paid time off (PTO).

• Short-term disability.

• Long-term disability.

• Parental leave.

• At-will employment.

• Equal opportunity employment.