Regulatory Affairs Specialist

Job Description

Job Description

Job Title: Regulatory Affairs Specialist Job Description

The Regulatory Affairs Specialist assists the regulatory team with preparing, submitting, and maintaining regulatory filings required to market medical devices globally. This role requires an intermediate understanding of medical devices, their clinical and technical use, and the regulatory submission process. The specialist supports regulatory strategy, documentation, and communication activities to ensure products comply with applicable regulations and can be successfully introduced and maintained in the market.

• Assist with the preparation, assembly, distribution, storage, tracking, and retrieval of documentation related to the regulatory process, including regulatory submissions.
• Author and publish electronic regulatory documents and respond to information requests from foreign governments and distributors as needed.
• Support research and analysis to determine the appropriate regulatory pathway for new or modified products, and clearly communicate findings to relevant stakeholders.
• Serve as a core team member on development project teams by providing regulatory direction and contributing to the development of regulatory strategies for new products.
• Evaluate the risks associated with proposed regulatory strategies and provide recommendations or alternative solutions when appropriate.
• Review proposed product labeling to ensure compliance with applicable global regulations.
• Write and manage the development, review, and maintenance of package inserts for medical devices.
• Review and evaluate promotional and advertising materials to verify compliance with applicable regulatory requirements.
• Assess proposed product changes and determine their impact on the regulatory status of the product.
• Communicate with regulatory and governmental agencies under supervision, ensuring timely and accurate responses.
• Apply FDA regulations to business practices and provide regulatory input, advice, and guidance to design and development teams.
• Collaborate closely with cross-functional teams, including engineering and quality, to ensure regulatory requirements are understood and integrated into product development and lifecycle management.

• Bachelor’s degree (or non-US equivalent) required, preferably in life sciences, technical/engineering, or a related field.
• Minimum of 3 years of experience in Regulatory Affairs, Engineering, Quality, or a related field.
• Intermediate understanding of medical devices and their use in clinical and technical settings.
• Demonstrated experience with regulatory submissions and regulatory filings for medical devices.
• Working knowledge of FDA regulations and their application to medical device business practices.
• Experience with regulatory documentation, including authoring, organizing, and maintaining regulatory files.
• Ability to review and interpret global regulatory requirements, including labeling, promotion, and advertising regulations.
• Strong analytical skills to evaluate regulatory strategies and assess risk.
• Effective written communication skills for drafting regulatory documents, package inserts, and responses to regulatory agencies.
• Strong attention to detail and organizational skills for managing multiple regulatory projects and documentation streams.

• A minimum of one year of experience in the orthopaedic or broader medical device industry is preferred.
• Regulatory Affairs Certification (US or EU) is preferred.
• Experience with EU Medical Device Regulation (EU MDR) is beneficial.
• Background in Quality Assurance or related quality functions is an advantage.
• Familiarity with global regulatory requirements and interactions with foreign regulatory bodies is desirable.
• Ability to collaborate effectively with cross-functional teams, including development, engineering, and quality.
• A combination of relevant education and experience may be considered in lieu of strict requirements.

This position is 100% on-site in Warsaw, IN. The role operates in a professional office and regulated medical device environment that emphasizes compliance, documentation accuracy, and collaboration with cross-functional teams. The specialist works closely with engineering, quality, and development groups, as well as interacts with regulatory and governmental agencies under supervision. Standard office technology and electronic document management systems are used to prepare, submit, and track regulatory documentation. The work setting supports focused, detail-oriented tasks and frequent communication with internal stakeholders to ensure regulatory requirements are consistently met.

This is a Contract position based out of Warsaw, IN.

The pay range for this position is $50.00 - $55.00/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)

This is a fully onsite position in Warsaw,IN.

This position is anticipated to close on Aug 28, 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 withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email View email address on ziprecruiter.com for other accommodation options.

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

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall 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 applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.