Job ID: 3179822
Overview of the Regulatory Engineer/Specialist Role
Concord IT Systems is seeking a highly motivated and experienced Regulatory Engineer or Regulatory Specialist to join our dedicated team. This remote, full-time position offers a unique opportunity to contribute to the product registration and compliance efforts for medical devices across various international markets. While primarily remote, this role requires occasional travel to client sites in Pittsburgh, PA, or Bothell, WA, on an as-needed basis. We are looking for a professional with a strong background in regulatory affairs within the medical device industry, capable of navigating complex global regulatory landscapes.
The ideal candidate will possess a comprehensive understanding of regulatory requirements for medical devices, particularly in APAC, LATAM, EMEA, Canada, China, Russia, Japan, and other key regions. You will be instrumental in preparing and reviewing documentation for product registrations, renewals, change submissions, and re-registrations, ensuring strict adherence to local and international standards. This role demands meticulous attention to detail, excellent organizational skills, and the ability to effectively communicate with internal teams and external regulatory bodies.
Key Responsibilities
- Provide comprehensive product registration support for assigned countries within APAC, LATAM, EMEA, Canada, China, Russia, Japan, and other regions.
- Prepare and meticulously review all necessary documentation for the renewal, change submission, notification, and re-registration of medical devices.
- Perform continuous regulatory watch activities to identify and respond proactively to new or revised regulatory requirements, incorporating input from Geo RAs.
- Track the status of applications under regulatory review, providing regular and timely updates to the Core Regulatory team.
- Maintain detailed logs of all communications and outcomes with regulatory authorities and other relevant internal or external stakeholders.
- Collect, organize, and maintain comprehensive files on local, regional, and global regulatory intelligence and related information.
- Research specific requirements (local, national, international) and explore various options for regulatory submissions, approval pathways, and compliance activities.
- Manage and maintain information systems (both electronic and paper-based) for regulatory information and reports, ensuring accuracy and accessibility.
- Oversee and ensure the timely renewal of all regulatory licenses.
- Clearly convey complex regulatory information and updates to peers, supervisors, and other stakeholders.
- Support the ongoing development and improvement of internal Regulatory Affairs (RA) systems and procedures.
Essential Qualifications and Experience (‘Must to Have’)
- Demonstrated experience in product registration support across multiple regions, including APAC, LATAM, EMEA, Canada, China, Russia, and Japan.
- Proficiency with regulatory bodies and frameworks such as Health Canada, TGA, HAS, CFDA/NMPA, TFDA, PMDA, Anvisa ANMAT, MFDS, MOHW, and SFDA/MOH.
- Extensive experience with global regulatory submissions and international submission processes.
- Proven track record in medical device registration, re-registration, and regulatory license renewals.
- Experience in managing change submissions and notifications.
- Ability to prepare STED (Summary of Technical Documentation) documents.
- Understanding of regulatory approbation processes.
- Familiarity with EU MDD/MDR Technical documentation Summary.
- Experience interacting with Notified Bodies.
- Proficiency in preparing CE Technical Files / EU Technical Files / Design Dossiers.
Valuable Additions to Your Profile (‘Adds Value’)
- Regulatory submission experience specifically for Electromechanical Class IIB and Class III devices.
- RAC (Regulatory Affairs Certification) for Medical Devices.
- Experience with FDA 510(K) and PMA (Premarket Approval) Submissions.
- Knowledge of Collateral/Product specific IEC Standards.
- Ability to support EU MDR Transition activities.
- Experience in conducting EU MDR Gap Analysis.
Preferred Skillsets
- In-depth knowledge of geography-specific regulatory requirements for medical devices, particularly in APAC and LATAM regions.
- Experience with Class III implants.
This role is critical for ensuring our clients’ medical devices meet all necessary regulatory standards, facilitating market access and patient safety. If you are a dedicated Regulatory professional with a passion for the medical device industry and a desire to make a significant impact, we encourage you to apply. Join Concord IT Systems and contribute to advancing healthcare innovation.
Special Requirements
Need to travel to Pittsburgh, PA/Bothell, WA on need basis.
Compensation & Location
Salary: $70,000 – $130,000 per year (Estimated)
Location: Remote, USA
Recruiter / Company – Contact Information
Recruiter / Employer: Concord IT Systems
Email: sandy.steve@concorditsystems.com
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