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SThree

Regulatory Affairs Specialist

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Job Description

Regulatory Affairs Specialists play a critical role in guiding organizations through complex compliance frameworks, ensuring that products and processes meet evolving regulatory requirements while maintaining robust quality systems. This position could involve navigating industry-specific regulations, conducting risk assessments, and implementing audit management strategies that protect organizational integrity. Please note the content of this advert does not represent a live vacancy. About the opportunity This is an opportunity to register your interest in future Regulatory Affairs Specialist roles focused on compliance framework management, risk assessment, and quality system implementation. Roles of this type may sit within organizations that prioritize regulatory excellence and require deep expertise in navigating complex compliance landscapes across multiple jurisdictions and regulatory bodies. Typical role overview

Location:
Boston, Massachusetts, USA Type:

Permanent

•

Full-time Salary:

$110,000 - $190,000 per annum, dependent on experience

Domain:

Regulatory Affairs

• Compliance

• Quality Systems What you would do Typical responsibilities could include: Managing regulatory submissions and maintaining ongoing compliance with industry-specific regulations Conducting risk assessments and implementing mitigation strategies across quality systems Leading or contributing to internal and external audit preparation, execution, and follow-up activities Developing and maintaining compliance documentation and standard operating procedures Collaborating with cross-functional teams including quality assurance, operations, and legal to ensure alignment with regulatory requirements Monitoring regulatory landscape changes and translating them into organizational policy updates Supporting regulatory strategy and providing compliance guidance to stakeholders What you could bring Most roles of this type require the following: Must-have 5-10 years of regulatory affairs, compliance, or quality assurance experience Demonstrated knowledge of regulatory frameworks relevant to your industry (FDA, EPA, ISO standards, or equivalent) Experience with audit management, risk assessment, and compliance documentation Working knowledge of quality system implementation and maintenance Strong analytical and communication skills Bachelor's degree in Engineering, Business, Finance, Accounting, or related field Authorization to work in the United States Nice-to-have Certified Compliance Professional (CCP) certification Experience with QARA (Quality Assurance and Regulatory Affairs) integration Master's degree or advanced compliance certification Experience across multiple regulatory jurisdictions What roles of this type could offer Most roles of this type offer the following, dependent on the industry and seniority of the role: Opportunity to develop deep expertise in regulatory compliance and quality systems Exposure to cross-functional collaboration with operations, engineering, and executive leadership Potential progression toward senior or lead compliance roles with expanded responsibility Professional development in emerging regulatory trends and compliance frameworks Comprehensive benefits package, including health coverage, paid time off, retirement planning, and flexible work arrangements where supported by the role About Specialist Staffing Group Specialist Staffing Group connects talented regulatory, compliance, and risk management professionals with organizations seeking to build or strengthen their governance and compliance capabilities. We specialize in placing experienced professionals who understand the complexities of regulatory affairs and can drive meaningful compliance outcomes. How to register interest If you are interested in being added to our database to be considered for future opportunities, registering is quick and easy. No cover letter required. We will be in touch when we are instructed on these roles to discuss the next step in your career. Please note that the content of this advert does not represent a live vacancy or any guarantee of future vacancies, and by responding to this advert you agree to us adding your details to our database for future opportunities.

Benefits

  • Paid Time Off (PTO)
  • Professional Development
  • Dental Insurance