Sr. Regulatory Affairs Specialist

Job Title: Regulatory Affairs Specialist

As a Regulatory Affairs Specialist, you will play a pivotal role in shaping and executing regulatory strategies on a local, regional, and global scale. You will be responsible for evaluating the regulatory environment and providing internal advice to ensure product compliance throughout its lifecycle, from concept to market. Your expertise will help anticipate regulatory challenges and develop innovative solutions to maintain compliance and market access.

Responsibilities

• Assess regulatory intelligence to assist in developing regulatory strategies.
• Participate in advanced advocacy activities to influence regulatory decisions.
• Evaluate the regulatory environment and provide internal advice for product compliance throughout the product lifecycle.
• Anticipate regulatory obstacles and emerging issues, developing solutions to overcome them.
• Identify requirements and potential obstacles for market access distribution at various levels.
• Assist in developing and updating regulatory strategies based on changes in regulations.
• Evaluate proposed products for regulatory classification and jurisdiction.
• Determine requirements and options for regulatory submissions and approval pathways.
• Provide regulatory information and guidance for product development and planning.
• Compare regulatory outcomes with initial product concepts, recommending changes as necessary.
• Negotiate with regulatory authorities throughout the product lifecycle.
• Identify and develop new regulatory procedures and standard operating procedures (SOPs).
• Train stakeholders on regulatory requirements to ensure compliance organization-wide.
• Assist other departments in developing SOPs for regulatory compliance.
• Provide regulatory input and technical guidance on global regulatory requirements.
• Advise stakeholders on regulatory requirements for quality, preclinical, and clinical data.
• Assess the acceptability of documents for regulatory submissions.
• Evaluate proposed changes for regulatory filing solutions and strategize as needed.
• Provide knowledge and guidance on preapproval inspections and clinical investigator relationships.
• Identify and submit applicable reports or notifications to regulatory authorities.
• Provide regulatory information and guidance for proposed product claims and labeling.
• Ensure that data and regulatory strategy align with requirements and support product claims.
• Prepare and submit electronic and paper regulatory submissions according to guidelines.
• Monitor the progress of regulatory reviews and communicate with agencies as necessary.
• Work with cross-functional teams for interactions with regulatory authorities.
• Remediate regulatory documentation for US 510(k) and EU MDR Technical Documentation File.

Essential Skills

• BS in Engineering, Science, or related degree; or MS in Regulatory Science.
• Minimum of 6 years’ experience in regulatory affairs.
• Thorough knowledge of US and International Medical Device Regulations.
• Direct experience with US 510(k) and EU Class IIa devices.
• Proficiency in EU MDR Class IIa devices and maintaining Technical Documentation Files.

Additional Skills & Qualifications

• MS or RAC(s) preferred.
• Strong planning and management skills.
• Competency in regulatory pathways, risk-benefit analysis, and compliance.
• Ability to operate with latitude for unreviewed action or decision.
• Capacity to connect and relate well with diverse individuals.
• Willingness to accept challenging assignments and build capabilities.

Work Environment

This position is based on-site with a hybrid work model in Libertyville, IL. The role involves working with cross-functional teams and engaging in diverse regulatory activities that require collaboration and strategic thinking. The working environment is dynamic, providing opportunities for growth and development.

This is a Contract position based out of Cary, IL.

The pay range for this position is $64.45 - $64.45/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

This is a hybrid position in Cary,IL.

This position is anticipated to close on Jun 26, 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.

Salary : $64