Regulatory Affairs Specialist

Job Title: Regulatory Affairs Specialist

Job Description

As a Regulatory Affairs Specialist, you will play a critical role in supporting regulatory compliance and quality systems for medical devices. You will assist in preparing, compiling, formatting, and submitting regulatory filings and maintain regulatory records and product registrations.

Responsibilities

• Assist with the preparation, compilation, formatting, and submission of regulatory filings.
• Maintain regulatory records, product registrations, declarations of conformity, and submission documentation.
• Support regulatory agency correspondence and requests for additional information.
• Participate in U.S. and international product registration and approval activities.
• Support post-market regulatory requirements, including annual reports and regulatory updates.
• Assess regulatory impact of product changes, manufacturing transfers, and process modifications.
• Prepare regulatory documentation, certifications, authorization letters, technical dossiers, and customer compliance requests.
• Collaborate with Quality Assurance to maintain compliance with applicable regulations and standards.
• Support internal and external audit preparation activities.
• Ensure document control and regulatory records are maintained accurately.
• Assist with the development and maintenance of regulatory procedures and processes.
• Monitor regulatory changes and communicate potential business impacts.
• Partner with Engineering, Clinical, Manufacturing, and Quality teams to gather technical information for submissions.
• Track regulatory deliverables and project timelines.
• Support regulatory training and compliance awareness initiatives.
• Contribute to continuous improvement projects within the Regulatory Affairs function.
• Maintain regulatory databases and information management systems.

Essential Skills

• Experience in regulatory affairs within the medical device industry.
• Hands-on experience supporting 510(k) submissions.
• Knowledge of FDA 21 CFR 820, ISO standards, and EU MDR 2017/745.
• Proficiency in regulatory submission processes.
• Strong written and verbal communication skills.
• Excellent organizational and project management abilities.
• Ability to work effectively with cross-functional teams.
• Proficient with Microsoft Office and standard business systems.

Additional Skills & Qualifications

• Bachelor"s degree in Regulatory Affairs, Biomedical Sciences, Engineering, Life Sciences, or a related field.
• 3-5 years of Regulatory Affairs experience within the medical device industry.
• Experience working in an FDA-regulated environment.
• Familiarity with quality systems and regulatory frameworks.

Work Environment

The work environment involves collaborating with cross-functional teams, including Engineering, Clinical, Manufacturing, and Quality. You will work with one other team member and report to the regulatory manager. This position requires proficiency in Microsoft Office and other standard business systems.

Job Type & Location

This is a Permanent position based out of Baldwin, NY.

Pay and Benefits

The pay range for this position is $75000.00 - $90000.00/yr.

Currently in Baildwin and moving to Woodbury later this year.

Workplace Type

This is a fully onsite position in Baldwin,NY.

Application Deadline

This position is anticipated to close on Jul 29, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.