Regulatory Affairs Specialist (Bedford, MA)
Determine and document change assessments for US Class II devices to ensure compliance with the US regulation. Plan and prepare submissions for US Class II devices, including creating, translating, revising, reviewing, and compiling documents, as well as responding to questions and requests from the FDA.
- Determine and document change assessments for EU Class III & IIb devices to ensure compliance with the EU Medical Device Regulation.
- Plan and prepare submissions for EU Class III & IIb devices, including creating, translating, revising, reviewing, and compiling documents, as well as responding to questions and requests from the Notified Body.
- Support submission and maintenance of product registrations in markets worldwide.
- Support product registrations, including creating, revising, reviewing and compiling documents for submission to regulatory authorities, as well as assisting in responding to questions and requests from such authorities.
- Assist in external audits by supporting responses to auditor questions and requests.
- Keep abreast of new or changed regulations and standards and perform gap analyses.
- Perform additional duties as assigned.
- (REQUIRED) Bachelor’s degree, preferably in the life sciences; advanced degree a plus.
- (REQUIRED) At least 3 years of experience in medical device field, including hands-on experience with submissions.
- Experience in regulatory submissions to medical device regulatory bodies a plus; e.g., FDA, Health Canada, ANVISA/INMETRO, EU NB, MHRA, Swissmedic, NMPA, PMDA, MFDS, and TGA.
- Experience with software-driven and electro-mechanical medical devices a plus.
- Strong knowledge of US and international requirements for regulatory submissions and maintenance of medical devices.
- Team player with ability to work independently in hybrid/in-person setting (Bedford, MA).
- Excellent and effective written and verbal communication skills.
- Excellent interpersonal skills, good judgment and analytical skills.
- Effective time management and organizational skills.
- Consistent, quality work and commitment to follow-through.
Recommended Jobs
Nurse Practitioner or Physician Assistant - Short Term Nursing Facility
Join a rapidly expanding hospitalist group dedicated to providing high-quality, patient-centered care in short-term nursing facilities in Hyannis, MA. We are seeking compassionate and skilled Nurse Pr…
Senior Manufacturing Engineer
Responsibilities for this Position Senior Manufacturing Engineer ID: 2026-70750 USA-MA-Pittsfield Required Clearance: Secret, obtainable within reasonable time based on requirements P…
Dining Manager
Who We Are: We believe a workplace food program is something employees should love and look forward to every day. Powered by technology and a network of over 2,000 restaurants, Fooda feeds hungry …
CNA - Certified Nurse Assistant
Description: We are looking for Certified Nursing Assistants (CNA) who want to make a difference! Flexible schedules and immediate start opportunities available! Benefits & Opportunit…
Medical Records Specialist
We are seeking a detail-oriented Medical Records Specialist to join our values- driven personal injury firm. The ideal candidate has experience with medical terminology, strong organizational skills,…
Associate PIP Litigation Attorney Needed (NEW!)
Attention Attorneys! We are an established, fast-paced PIP law firm in Salem, Massachusetts with a commitment to workplace community, personal development and work/life balance. We're looking for…
Customer Success Manager (B2B, Nebius Academy)
We are looking for an experienced Customer Success Manager to manage B2B clients across Europe and the US . This role combines account management, project coordination, and client support . Yo…
School Nurse
Company Overview Mystic Valley is a public charter school located in Malden Massachusetts. The school serves more than1,550 students in grades K-12 on four campuses in Malden: Kindergarten at 576 …
Speech Language Pathologist Home Health - Braintree float/Mayflower
Type: Home Health Newton , MA SkyBridge Healthcare is currently seeking Speech Language Pathologist with Home Health experience for a 13-week contract in MA. SkyBridge Healthcare is a premie…
Senior Account Executive
Ironside is seeking a Senior Account Executive to lead growth efforts across the New England territory. We’re looking for a customer-focused, relationship-driven solution seller—someone who leads …