Eliassen Group
Senior/ Principal Regulatory Affairs Specialist, Medical Device
Eliassen Group, Boston, Massachusetts, us, 02298
Senior / Principal Regulatory Affairs Specialist, Medical Device
Direct hire W2 only Senior/Principal Regulatory Affairs Specialist – Med Device. No opportunity for c2c engagement on this role.
Business Problem, Context & Initiative Description Our client is a privately held, innovation-driven
Class III medical device company
developing next‑generation laser and pulsed field ablation systems for atrial fibrillation. With
multiple First‑In‑Human programs ,
two active IDE clinical trials , and a rapidly advancing pipeline of new catheter and capital system technologies, the organization is entering a high‑stakes phase that demands a more technically capable and strategically aligned Regulatory Affairs function.
The company is redefining Regulatory Affairs as a deeply technical, engineering‑integrated discipline rather than a documentation‑only function. Unlike traditional RA roles, this group is expected to actively participate in bench work, engineering discussions, clinical interfaces, and early drafting of submissions and responses.
Duties / Expectations of This Role
Act as a
technical regulatory partner , collaborating closely with engineering, R&D, manufacturing, and clinical teams.
Develop and execute regulatory strategies for pivotal trials, IDE expansions, and commercialization pathways.
Lead or contribute to global submissions ( FDA Class II/III, EU MDR Class I/IIb/III ).
Prepare, collect, evaluate, and synthesize technical documentation, engineering data, clinical data, and test results.
Draft first and second versions of submission content and regulatory responses.
Serve as a key participant in engineering meetings, bench activities, and clinical review discussions.
Support and prepare for FDA, EU Notified Body, and partner audits.
Ensure alignment with FDA, EU MDR, EUDAMED, and global regulatory requirements.
Provide regulatory insight on design decisions, risk management, test standards, and manufacturing changes.
Support labeling/UDI, lifecycle management, and global post‑market requirements.
Establish strong onsite presence to evaluate issues directly and report back to remote leadership.
Work effectively in a high‑energy, high‑growth, multi‑project environment with frequent shifts in priorities.
Help evolve internal procedures, templates, documentation practices, and regulatory standards.
Must‑Haves – Qualification Summary
BS in Science or Engineering with technical medical‑device experience or background.
5–7 years of regulatory experience in medical devices (EP or cardiology strongly preferred).
Direct, hands‑on experience with FDA Class II & III submissions and EU MDR Class I/IIb/III.
Experience with FDA submission systems, EUDAMED, Authorized Reps, and Importers.
Demonstrated success supporting FDA and Notified Body audits.
Ability to interpret and apply test standards and technical requirements.
Experience writing initial drafts of submissions, responses, and regulatory documentation.
Ability to translate complex engineering data (software, electrical schematics, mechanical systems) into clear regulatory narratives.
Strong written and verbal technical communication skills.
Skilled in MS Office Suite and Adobe Pro (advanced features).
Highly organized with strong ability to manage multiple deadlines in a fast‑paced environment.
Capable of anticipating regulatory needs and guiding teams with sound regulatory judgment.
Nice to Have
Experience in startup or small, fast‑moving environments.
Clinical exposure – ability to support clinical documentation and interactions with Notified Bodies.
Familiarity with IEC standards, sterilization, biocompatibility, labeling requirements.
Experience reviewing promotional literature for compliance.
PMDA (Japan) or additional global regulatory experience.
Travel & Location Strong preference for candidates based in or near Marlborough, MA.
Compensation Competitive and aligned with experience and seniority level.
Job Details
Seniority level: Mid‑Senior level
Employment type: Full‑time
Job function: Engineering and Strategy/Planning
Industries: Medical Equipment Manufacturing
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Business Problem, Context & Initiative Description Our client is a privately held, innovation-driven
Class III medical device company
developing next‑generation laser and pulsed field ablation systems for atrial fibrillation. With
multiple First‑In‑Human programs ,
two active IDE clinical trials , and a rapidly advancing pipeline of new catheter and capital system technologies, the organization is entering a high‑stakes phase that demands a more technically capable and strategically aligned Regulatory Affairs function.
The company is redefining Regulatory Affairs as a deeply technical, engineering‑integrated discipline rather than a documentation‑only function. Unlike traditional RA roles, this group is expected to actively participate in bench work, engineering discussions, clinical interfaces, and early drafting of submissions and responses.
Duties / Expectations of This Role
Act as a
technical regulatory partner , collaborating closely with engineering, R&D, manufacturing, and clinical teams.
Develop and execute regulatory strategies for pivotal trials, IDE expansions, and commercialization pathways.
Lead or contribute to global submissions ( FDA Class II/III, EU MDR Class I/IIb/III ).
Prepare, collect, evaluate, and synthesize technical documentation, engineering data, clinical data, and test results.
Draft first and second versions of submission content and regulatory responses.
Serve as a key participant in engineering meetings, bench activities, and clinical review discussions.
Support and prepare for FDA, EU Notified Body, and partner audits.
Ensure alignment with FDA, EU MDR, EUDAMED, and global regulatory requirements.
Provide regulatory insight on design decisions, risk management, test standards, and manufacturing changes.
Support labeling/UDI, lifecycle management, and global post‑market requirements.
Establish strong onsite presence to evaluate issues directly and report back to remote leadership.
Work effectively in a high‑energy, high‑growth, multi‑project environment with frequent shifts in priorities.
Help evolve internal procedures, templates, documentation practices, and regulatory standards.
Must‑Haves – Qualification Summary
BS in Science or Engineering with technical medical‑device experience or background.
5–7 years of regulatory experience in medical devices (EP or cardiology strongly preferred).
Direct, hands‑on experience with FDA Class II & III submissions and EU MDR Class I/IIb/III.
Experience with FDA submission systems, EUDAMED, Authorized Reps, and Importers.
Demonstrated success supporting FDA and Notified Body audits.
Ability to interpret and apply test standards and technical requirements.
Experience writing initial drafts of submissions, responses, and regulatory documentation.
Ability to translate complex engineering data (software, electrical schematics, mechanical systems) into clear regulatory narratives.
Strong written and verbal technical communication skills.
Skilled in MS Office Suite and Adobe Pro (advanced features).
Highly organized with strong ability to manage multiple deadlines in a fast‑paced environment.
Capable of anticipating regulatory needs and guiding teams with sound regulatory judgment.
Nice to Have
Experience in startup or small, fast‑moving environments.
Clinical exposure – ability to support clinical documentation and interactions with Notified Bodies.
Familiarity with IEC standards, sterilization, biocompatibility, labeling requirements.
Experience reviewing promotional literature for compliance.
PMDA (Japan) or additional global regulatory experience.
Travel & Location Strong preference for candidates based in or near Marlborough, MA.
Compensation Competitive and aligned with experience and seniority level.
Job Details
Seniority level: Mid‑Senior level
Employment type: Full‑time
Job function: Engineering and Strategy/Planning
Industries: Medical Equipment Manufacturing
#J-18808-Ljbffr