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SThree

Regulatory Specialist

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Job Description

We are looking for a Regulatory Specialist to join our team in Boston, Massachusetts. This is an opportunity to register your interest in future Regulatory Specialist positions that could support the development and compliance of products within regulated industries, ensuring organizations maintain the highest standards of regulatory adherence and quality assurance. Please note the content of this advert does not represent a live vacancy. About the opportunity Roles of this type may sit within a collaborative compliance and regulatory affairs function, working to ensure that organizational practices align with evolving regulatory frameworks and industry standards. The work could involve partnering across quality, operations, and product development teams to maintain compliance with applicable regulations, manage audit processes, and support the implementation of robust quality systems. You could have scope to influence how regulatory strategy is developed and communicated across the business. Typical role overview

Location:

Boston, Massachusetts, USA — hybrid, with flexibility

Type:

Permanent

•

Full-time Salary:

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

Domain:

Regulatory affairs

• compliance management

• quality assurance What you would do Typical responsibilities could include: Managing regulatory submissions, filings, and correspondence with regulatory bodies Conducting compliance assessments and gap analyses across organizational processes Supporting the implementation and maintenance of quality management systems Coordinating internal and external audit activities and managing corrective action plans Monitoring regulatory changes and communicating impact to relevant departments Developing and updating regulatory documentation, policies, and standard operating procedures Collaborating with cross-functional teams to ensure regulatory requirements are integrated into product development and operations Providing guidance and training on regulatory compliance to colleagues What you could bring Most roles of this type require the following: Must-have 5-10 years of experience in regulatory affairs, compliance, or quality assurance Demonstrated knowledge of applicable regulatory frameworks and compliance requirements Experience with audit management and corrective action processes Strong understanding of quality systems and documentation practices Excellent written and verbal communication skills Authorization to work in the United States Nice-to-have Certified Compliance Professional (CCP) or equivalent certification Experience in a regulated industry such as medical device, pharmaceutical, or healthcare Familiarity with QARA (Quality Assurance and Regulatory Affairs) practices Project management experience Bachelor's degree in Engineering, Business, Finance, or Accounting What roles of this type could offer Most roles of this type offer the following, dependent on the industry and seniority of the role: The opportunity to shape how an organization approaches regulatory strategy and compliance Scope to develop expertise in regulatory frameworks and emerging compliance requirements Potential progression toward senior regulatory or compliance leadership roles Collaboration with cross-functional teams across quality, operations, and product development Professional development opportunities and support for certifications such as CCP Comprehensive benefits including health coverage, paid time off, retirement planning, and flexible working arrangements About Specialist Staffing Group We are a leading staffing and recruitment firm dedicated to connecting talented professionals with meaningful career opportunities. We specialize in identifying and placing candidates in regulatory, compliance, and quality-focused roles across regulated industries, helping both professionals and organizations achieve their strategic objectives. 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