Regulatory Affairs Associate II

Regulatory Affairs Associate II

The Regulatory Affairs Associate II plays a key role in bringing medical device products to patients by preparing and managing regulatory submissions and leading interactions with regulatory agencies. This role partners closely with internal cross-functional teams and external stakeholders to ensure compliance with applicable regulations and company procedures, with a particular focus on Class III implantable medical devices. The position requires a strong understanding of regulatory pathways, change control, and quality systems in a complex, matrixed environment.

Responsibilities

• Prepare regulatory submissions, including new applications, amendments, renewals, annual reports, supplements, and variations under limited supervision, and respond to regulatory information requests in a timely and accurate manner.
• Analyze and interpret regulatory, technical, and clinical information to support regulatory decisions, and seek expert advice and technical support as needed to develop robust regulatory strategies and submissions.
• Manage preparation for regulatory agency meetings, including planning timelines, coordinating inputs from cross-functional teams, and overseeing the content and quality of pre-meeting submissions.
• Manage regulatory aspects of products and change control activities, ensuring full alignment with applicable regulations as well as internal company policies and procedures.
• Author and submit PMA supplements, 30-Day Notices, Real-Time Reviews, 180-Day Supplements, and Annual Reports for Class III implantable medical devices, ensuring completeness, accuracy, and regulatory compliance.
• Review and approve engineering study protocols and reports to ensure they meet regulatory expectations and support ongoing and future submissions.
• Review and approve validation study protocols and reports to confirm they adequately demonstrate compliance with regulatory and quality requirements.
• Review and approve manufacturing changes for Class III implantable medical devices, ensuring that changes are appropriately assessed, documented, and supported by necessary regulatory submissions.
• Handle all interactions with government agencies related to the regulation process for products requiring governmental approval, including responding to questions, deficiencies, and other regulatory correspondence.
• Rely on extensive regulatory experience and professional judgment to plan, prioritize, and accomplish goals in a dynamic environment.
• Perform a variety of regulatory and compliance tasks, adapting to evolving priorities and project needs across multiple products or programs.
• Lead and direct the work of others as needed, providing guidance and oversight on regulatory tasks and contributing to the development of junior team members.
• Apply creativity and initiative to solve complex regulatory challenges, propose innovative approaches, and improve regulatory processes and documentation.

Essential Skills

• Bachelors degree in pharmacy, biology, chemistry, pharmacology, engineering, or a related scientific or technical discipline.
• 6 years of pharmaceutical or industry-related experience.
• 35 years of experience in quality systems or cross-functional project management.
• Recent hands-on experience working with Class III implantable medical devices.
• Proven successful track record of authoring, submitting, and achieving approval of PMA supplements for Class III implantable medical devices.
• Strong knowledge of FDA PMA guidance documents and applicable CFR regulations.
• Demonstrated ability to prepare and manage regulatory submissions such as PMA supplements, 30-Day Notices, Real-Time Reviews, 180-Day Supplements, and Annual Reports.
• Experience managing regulatory aspects of change control and manufacturing changes for medical devices, particularly Class III implantables.
• Experience working effectively in a complex, matrixed organizational environment, collaborating across multiple functions and stakeholders.
• Strong oral communication skills, with the ability to present regulatory issues and strategies clearly to technical and non-technical audiences.
• Strong written communication skills, with the ability to draft clear, well-structured regulatory documents and correspondence.
• Ability to exercise sound judgment, prioritize multiple projects, and meet deadlines with limited supervision.
• Ability to lead or direct the work of others on regulatory projects when required.

Additional Skills & Qualifications

• Advanced degree in a relevant scientific or technical discipline is preferred.
• 6 years of pharmaceutical experience, including 5 years in regulatory affairs, or 5 years in Discovery R&D or Manufacturing, is preferred.
• Experience authoring and reviewing engineering and validation study protocols and reports.
• Experience coordinating and managing content for regulatory agency meetings.
• Demonstrated ability to interpret complex regulatory and technical information and translate it into clear regulatory strategies and documentation.
• Comfort working with a wide degree of creativity and latitude to address regulatory and process challenges.
• Strong collaboration skills and the ability to build effective relationships across quality, manufacturing, R&D, and other functions.

Work Environment

This position operates in a hybrid work environment based in Lake County, combining on-site and remote work. The role involves frequent collaboration with cross-functional teams in a complex, matrixed organization, requiring regular virtual and in-person meetings. Work is primarily office-based, focused on document preparation, review, and communication using standard business and regulatory software tools. The schedule generally follows standard business hours, with flexibility as needed to meet regulatory deadlines and support time-sensitive submissions and agency interactions.

Job Type & Location

This is a Contract position based out of North Chicago, IL.

Pay and Benefits

The pay range for this position is $40.00 - $43.00/hr. 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.

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)

Workplace Type

This is a hybrid position in North Chicago,IL.

Application Deadline

This position is anticipated to close on Oct 6, 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.