"Alerted.org

Senior/ Principal Regulatory Affairs Specialist

Marlborough, MA

**Type:** Permanent

**Category:** Q&R

**Industry:** Life Sciences

**Reference ID:** JN -122025-104650

**Date Posted:** 01/03/2026

**Shortcut:** http://careers.eliassen.com/FxXYFE

+ Description

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Description:

_Onsite in Marlborough, MA_

Our client is a privately held Class III medical device organization developing laser and pulsed field ablation systems for atrial fibrillation. The regulatory function integrates with engineering and clinical teams and contributes to bench work, design discussions, and early drafting of submissions. The role supports two IDE programs, accelerates global submissions, strengthens Notified Body interactions, and provides an onsite regulatory presence in a fast-paced, multi-project environment.

_This is a full-time, permanent opportunity, offering a competitive salary and comprehensive benefits package. Qualified applicants must be willing and able to work on a w2 basis._

Salary: $110,000 - $140,000/ yr. w2

Responsibilities:

Responsibilities

+ Act as a technical regulatory partner collaborating 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 for FDA Class II/III and EU MDR Class I/IIb/III devices.

+ 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.

+ Participate 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 input on design decisions, risk management, test standards, and manufacturing changes.

+ Support labeling and UDI, lifecycle management, and global post-market requirements.

+ Establish a strong onsite presence to evaluate issues and report to remote leadership.

+ Operate effectively in a high-growth, multi-project environment with shifting priorities.

+ Help evolve internal procedures, templates, documentation practices, and regulatory standards.

Experience Requirements:

Experience Requirements

+ 5–7 years of regulatory experience in medical devices, with electrophysiology or cardiology preferred.

+ Direct, hands-on experience with FDA Class II and III submissions and EU MDR Class I/IIb/III.

+ Experience with FDA submission systems, EUDAMED, Authorized Representatives, and Importers.

+ Proven 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 software, electrical, and mechanical engineering data into clear regulatory narratives.

+ Strong written and verbal technical communication skills.

+ Proficiency with MS Office Suite and Adobe Pro.

+ High organization and ability to manage multiple deadlines in a fast-paced environment.

+ Ability to anticipate regulatory needs and guide teams with sound judgment.

+ Nice to have: Class III cardiac, electrophysiology, or ablation device experience.

+ Nice to have: Startup or small-company experience.

+ Nice to have: Clinical exposure supporting documentation and Notified Body interactions.

+ Nice to have: Familiarity with IEC standards, sterilization, biocompatibility, and labeling requirements.

+ Nice to have: Experience reviewing promotional literature for compliance.

+ Nice to have: PMDA or additional global regulatory experience.

Education Requirements:

Education Requirements

+ BS in Science or Engineering.

_Recruitment Transparency Notice_

_Eliassen Group values transparency in our recruitment practices. Please be advised that Eliassen Group utilizes artificial intelligence (AI) tools as part of its initial application screening process. You may receive email and SMS notifications from the Eliassen Virtual Recruiting Team (_** **[email protected]_** **_, 781-808-2924) inviting you to complete a brief voice screening as part of your application process. These tools assist our hiring teams in different ways, including but not limited to, assistance in reviewing application materials to help identify candidates whose qualifications most closely match the requirements of the position. All AI-assisted evaluations and responses are reviewed by human recruiters before any hiring decisions are made. The use of AI in our process is intended to support fairness, efficiency, and consistency, and Eliassen Group takes measures to prevent bias or discrimination in connection with its hiring practices. By proceeding, you acknowledge, agree, and consent to Eliassen Group’s use of these tools, including AI tools, as part of the application and hiring process._

_Skills, experience, and other compensable factors will be considered when determining pay rate. The pay range provided in this posting reflects a W2 hourly rate; other employment options may be available that may result in pay outside of the provided range._

_W2 employees of Eliassen Group who are regularly scheduled to work 30 or more hours per week are eligible for the following benefits: medical (choice of 3 plans), dental, vision, pre-tax accounts, other voluntary benefits including life and disability insurance, 401(k) with match, and sick time if required by law in the worked-in state/locality._

_Please be advised- If anyone reaches out to you about an open position connected with Eliassen Group, please confirm that they have an Eliassen.com email address and never provide personal or financial information to anyone who is not clearly associated with Eliassen Group. If you have any indication of fraudulent activity, please contact_ [email protected]_ _._

_About Eliassen Group:_

_Eliassen Group is a leading strategic consulting company for human-powered solutions. For over 30 years, Eliassen has helped thousands of companies reach further and achieve more with their technology solutions, financial, risk & compliance, and advisory solutions, and clinical solutions. With offices from coast to coast and throughout Europe, Eliassen provides a local community presence, balanced with international reach. Eliassen Group strives to positively impact the lives of their employees, clients, consultants, and the communities in which they operate._

_Eliassen Group is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status._

_Don’t miss out on our referral program! If we hire a candidate that you refer us to then you can be eligible for a $1,000 referral check!_