Spark Life Solutions Inc · 3 hours ago
Regulatory Affairs Specialist
Massachusetts, United States
Contract
Onsite
Mid Level
3+ years expSpark Life Solutions Inc is seeking a Regulatory Affairs Specialist to support the Life Cycle Management (LCM) Regulatory Affairs team. This role ensures compliance with European and U.S. medical device regulations throughout the product lifecycle by preparing and maintaining technical documentation.
Staffing & Recruiting
Hiring Manager
M D Shanawaz
Responsibilities
Support the LCM Regulatory Affairs group in preparing and maintaining technical documentation for medical devices
Ensure compliance with:
European Council Directive 93/42/EEC and/or Regulation (EU) 2017/745 (MDR)
U.S. FDA regulations, including 510(k) submissions and Notes to File
Assist in regulatory submissions, change assessments, and documentation updates
Collaborate with cross-functional teams including Quality, Engineering, and R&D
Ensure alignment with applicable standards, guidance documents, and regulatory requirements
Qualification
Required
Bachelor's (minimum 3 years' experience) or Master's (minimum 2 year of experience)
Degree in life sciences or engineering is required; or Advanced Degree (PhD with 1-2 years of experience) is preferred
3 to 5 years of experience in Medical Device industry especially within regulatory, quality or alternatively within engineering
Proven exceptional written and oral communication skills
Strong knowledge of ISO 13485 and ISO 9001, QSR
Medical Devices applicable requirements, especially Council Directive 93/42/EEC and Regulation 2017/745, as they pertain to technical documentation
MEDDEV guidance documents applicable to Medical Devices products and processes FDA requirement
Company
Spark Life Solutions Inc
Welcome to a partnership focused on excellence.
51-200 employees
H1B Sponsorship
Spark Life Solutions Inc has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
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Trends of Total Sponsorships
2025 (11)
2024 (7)
Funding
Current Stage
Growth StageCompany data provided by crunchbase