Senior/ Principal Regulatory Affairs Specialist
Marlborough, MA
Category: Q&R
Industry: Life Sciences
Reference ID: JN -122025-104650
Date Posted: 01/03/2026
Shortcut: http://careers.eliassen.com/FxXYFE
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.
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 InfoSec@eliassen.com.
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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. Eliassen Group’s Affirmative Action Plan (AAP) is available for inspection by any employee or applicant for employment upon request, during normal business hours of Monday through Friday, 8:30am to 5:30pm EST. Interested persons should contact Phaedra Wells at pwells@eliassen.com for assistance. It is unlawful in Massachusetts and Maryland to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Applicants with disabilities that believe they require an accommodation or assistance with a position, please email our HR team at hradmin@eliassen.com. This email inbox is designed exclusively to assist job seekers whose disability prevents them from being able to apply online. Emails sent for other purposes will not receive a response.
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