Regulatory Specialists play a vital role in helping organizations navigate complex compliance frameworks, manage risk assessments, and maintain quality systems that protect patients and ensure market access. This is an opportunity to register your interest in future Regulatory Specialist positions where you could contribute your expertise to drive compliance excellence and support product success in a dynamic healthcare or life sciences environment. 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 Specialist roles within quality, risk and compliance functions. Roles of this type sit at the intersection of regulatory strategy and operational delivery, working to interpret evolving regulations, assess organizational risk, and implement quality systems that keep products compliant and competitive. You could partner across cross-functional teams to translate regulatory requirements into practical controls, support audit readiness, and help shape the standards that guide your organization's approach to compliance. Typical role overview

Location:

New York, New York, USA Type:

Contract

•

Full-time Rate:

$560 - $800 per day

Domain:

Regulatory affairs

• Compliance

• Quality and Risk Management What you would do Typical responsibilities could include: Interpreting and translating regulatory requirements (FDA, EU

MDR, ISO

13485, GxP) into organizational policy and operational controls Conducting risk assessments and compliance gap analyses across quality systems, document management, and product lifecycle processes Supporting audit preparation, audit response and remediation tracking for internal and external audits Advising cross-functional teams on regulatory pathways, submission strategies and compliance obligations Maintaining and improving quality management systems, including documentation, training records and compliance evidence Monitoring regulatory intelligence and communicating emerging requirements to relevant stakeholders Collaborating with quality, operations and commercial teams to embed compliance into product development and commercialization activities What you could bring Most roles of this type require the following: Must-have 5-10 years of regulatory affairs, compliance, quality or risk management experience, ideally in medical device, pharmaceutical or healthcare Working knowledge of FDA regulations (21 CFR, design controls, adverse event reporting), EU

MDR, ISO

13485 and GxP principles Demonstrated experience conducting compliance assessments, gap analyses and audit management Strong understanding of quality system design, document control and change management Excellent written and oral communication skills; ability to translate complex regulatory concepts for non-technical audiences Authorization to work in the United States Bachelor's degree in Engineering, Business, Finance, Accounting or related field Nice-to-have Certified Compliance Professional (CCP) or equivalent regulatory certification Experience with regulatory submissions, pre-market notifications or post-market surveillance Familiarity with quality management software and document control platforms Project management or cross-functional team leadership experience 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 influence how your organization manages regulatory risk and maintains compliance excellence Exposure to varied regulatory challenges across product development, operations and market access Scope to develop deeper expertise in specific regulatory domains (e.g., design controls, adverse event reporting, international submissions) Potential to mentor junior compliance team members and contribute to process improvement initiatives Professional development aligned with evolving regulatory standards and industry best practices Flexibility, collaborative culture and the satisfaction of work that supports patient safety and product integrity About Specialist Staffing Group Specialist Staffing Group partners with leading organizations across healthcare, life sciences, engineering and professional services to connect skilled professionals with meaningful opportunities. We focus on regulatory, quality, compliance and technical talent, helping both organizations and professionals navigate complex, specialized roles where expertise makes a measurable difference. 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.