Regulatory Affairs Specialist

Job Title: Regulatory Affairs Specialist As a Regulatory Affairs Specialist, you will perform thorough regulatory assessments for proposed changes to current products, ensuring compliance with local and regional registration requirements. You will provide regulatory support for line extensions and supplier change requests and conduct in-depth reviews of product literature and marketing collateral, particularly for Class II devices, to ensure regulatory compliance. Additionally, you will monitor and improve tracking and control systems, while staying informed about regulatory procedures and changes. Responsibilities Conduct comprehensive regulatory assessments for proposed product changes, including supplier request changes, and document all related activities to ensure compliance. Demonstrate global regulatory expertise for change assessments in line with local regulations. Collaborate with various departments to review required plans, procedures, and regulatory decisions for existing products or line extensions. Review product literature and other marketing collateral to ensure regulatory compliance. Stay abreast of regulatory and technical developments in the industry by reviewing technical publications, articles, and abstracts. Adhere to company codes of conduct and policies, ensuring compliance with applicable governmental laws, rules, and regulations both domestically and internationally. Represent the company professionally, upholding high standards of ethical business practices and socially responsible conduct in interactions with employees, customers, suppliers, and third parties. Essential Skills Regulatory affairs expertise, particularly with Class II medical devices. Experience in regulatory impact assessments for product, process, supplier, material, and component changes. Sustaining regulatory support for existing commercial products. Device labeling and marketing review, including instructions for use, product literature, claims, and promotional materials. Knowledge of U.S. and international regulatory requirements, including 510(k), EU MDR, and global registrations. Familiarity with regulatory submissions and interactions with regulatory agencies, such as the FDA. Additional Skills & Qualifications Typically requires a minimum of 2 years of related experience with a Bachelor's degree, or 1 year with a Master's degree, or equivalent work experience. Two or more years of related experience in the medical device industry. Understanding of regulatory requirements throughout the product lifecycle. Solid understanding of regulatory terminology, pre-market submission types, and requirements. Ability to evaluate the regulatory impact of proposed product and process changes. Strong multi-tasking skills with the ability to plan projects and meet deadlines. Result-driven with a sense of responsibility, urgency, and the ability to perform under pressure. Work Environment This position requires working on-site 5 days a week in Audubon, PA. Employees will gain broad, hands-on medical device regulatory affairs experience while supporting products throughout their commercial lifecycle. The role offers cross-functional exposure, experience with both U.S. and international requirements, and the opportunity to make visible regulatory decisions that help maintain compliant products in the market. Job Type & Location This is a Permanent position based out of West Norriton, PA. Pay And Benefits The pay range for this position is $80000.00 - $82000.00/yr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. $82,000 a year with an Annual bonus of $3,000 Full benefits package, 401(k) with a 4% company match, 22 total PTO days at the start: o 15 vacation days o 5 sick days o 2 personal days o 9 paid holidays Workplace Type This is a fully onsite position in West Norriton,PA. Application Deadline This position is anticipated to close on Oct 16, 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 View email address on click.appcast.io 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. #J-18808-Ljbffr Actalent