Regulatory Affairs Specialists play a critical role in ensuring that products and services meet complex compliance frameworks and regulatory standards. This is an opportunity to register your interest in future Regulatory Affairs Specialist positions where you could contribute to maintaining quality systems and managing regulatory submissions in a dynamic, highly regulated environment. Please note the content of this advert does not represent a live vacancy. About the opportunity Roles of this type sit within organizations where regulatory expertise directly shapes product approval timelines and market access strategies. You could find yourself coordinating cross-functional teams to navigate regulatory requirements, prepare submissions, and maintain compliance frameworks that protect both the organization and the public. This is contract work based in New York, New York, USA, offering the flexibility and focus that specialized regulatory roles demand. Typical role overview

Location:

New York, New York, USA Type:

Contract •

Full-time Rate:

$560 - $800 per day

Focus:

Regulatory compliance, submissions, quality systems, risk assessment What you would do Typical responsibilities could include: Preparing, reviewing and submitting regulatory documentation and applications to relevant authorities Monitoring changes in regulatory requirements and ensuring organizational compliance with evolving standards Coordinating with cross-functional teams (quality, engineering, medical affairs) to gather information for submissions and compliance activities Conducting regulatory risk assessments and identifying gaps in current compliance frameworks Maintaining and updating standard operating procedures and quality system documentation Supporting internal and external audit preparation and response Tracking regulatory timelines, deadlines and post-market obligations Advising internal stakeholders on regulatory strategy and compliance pathways 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 relevant regulatory frameworks and submission processes Experience with regulatory submissions, compliance audits and quality system documentation Strong organizational and project management skills Ability to interpret complex regulatory guidance and communicate requirements clearly Bachelor's degree in Engineering, Business, Finance/Accounting or a related field Authorization to work in the United States Nice-to-have Certified Compliance Professional (CCP) or equivalent regulatory certification Experience in medical device, pharmaceutical or healthcare industries Familiarity with FDA regulations, ISO 13485 or comparable quality standards Advanced proficiency in regulatory information management systems 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 regulatory strategy and ensure organizational compliance with critical standards Exposure to cross-functional collaboration across quality, engineering and commercial teams Clear visibility into how your work directly supports product approval and market access Potential for contract extension based on performance and business needs Professional development through engagement with evolving regulatory landscapes Flexibility inherent in contract-based work arrangements About Specialist Staffing Group Specialist Staffing Group connects regulatory, compliance and risk management professionals with organizations where specialized expertise directly impacts business outcomes. We focus on placing talented individuals in roles where their knowledge of regulatory frameworks, quality systems and compliance processes creates measurable value. 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.