Sr. Regulatory Affairs Specialist

Description:

Seeking a Sr. Regulatory Affairs Specialist to provide contract support for regulatory change assessments related to U.S. FDA and EU MDR requirements.

This role will focus on evaluating manufacturing and design changes, preparing regulatory submission documentation, and supporting global regulatory strategies throughout active development and production programs.

The specialist will work cross‑functionally with engineering, manufacturing, and quality teams while serving as a key regulatory resource onsite.

Experience with medical device regulatory submissions, change assessments, and FDA/EU compliance is required.

Day-to-Day: Work with Manufacturing/Engineering to process changes to machining, capital equipment, and tooling. Ensuring these changes align with US FDA & EU MDR regulatory standards.

Responsibilities:

• Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
• Leads or compiles all materials required in submissions, license renewal and annual registrations.
• Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
• Monitors and improves tracking / control systems.
• Keeps abreast of regulatory procedures and changes.
• May direct interaction with regulatory agencies on defined matters.
• Recommends strategies for earliest possible approvals of clinical trials applications.

Skills & Qualifications

• Experience with ISO 11607‑1 and ISO 11607‑2, including packaging system design and process validation for terminally sterilized medical devices
• Familiarity with packaging standards such as ASTM and ISTA
• Working knowledge of FDA 21 CFR Part 820 and general Quality System Regulation requirements
• Prior experience interfacing with Notified Bodies on EU MDR change notifications
• Experience supporting cross‑functional teams during design or manufacturing changes in a regulated medical device environmen

This is a Contract position based out of Lafayette, CO.

The pay range for this position is $35.00 - $50.00/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 fully onsite position in Lafayette,CO.

This position is anticipated to close on Apr 17, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.