Regulatory Specialist II

Company: Actalent
Location: South Portland
Posted on: January 18, 2026

Job Description:

Job Description Job Description Actalent is hiring a Regulator Specialist for a global healthcare group in the South Portland area SUMMARY The position of Regulatory Affairs Specialist II is within Infectious Disease business unit. In this role you will prepare documentation for EU Technical Files and international product registrations. RESPONSIBILITIES: Responsible for technical writing of files in accordance with In Vitro Diagnostic medical device Regulation IVDR. Provides regulatory support for diagnostic product development and commercial diagnostic products. Develops regulatory strategies for products in development and for modified products to achieve clearance/approval in the EU and internationally. Provides regulatory support to regional regulatory teams to assist with submissions license renewals and license amendments. Researches and communicates scientific and regulatory information in order to write submission documents. Compiles and publishes all material required for submissions license renewals and annual registrations. Maintains approvals/licenses/authorizations for existing marketing authorizations. Assesses product manufacturing and labeling changes for regulatory reporting impact and compliance to regulations. Develops internal procedures and tools. Conducts informational or training sessions for stakeholders. Organizes and maintains hard copy and electronic department files. Demonstrates commitment to the development implementation and effectiveness of the Quality Management System per ISO FDA and other regulatory agencies. Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices. BASIC QUALIFICATIONS EDUCATION: Bachelors Degree in Biology Chemistry Biochemistry Engineering or other related technical field or the equivalent combination of education and experience. 4 years experience in Regulatory Affairs role. Strong knowledge of IVDR and EU regulatory requirements is required. PREFERRED QUALIFICATIONS: 1 years experience in an IVD or medical device manufacturing environment. COMPETENCIES: Good knowledge of EU and international regulations. Demonstrated written and verbal communication skills. Strong time management skills with the ability to work on multiple projects simultaneously. Ability to work independently as well as within a team. Proficiency with Microsoft Office including Word Excel PowerPoint and Visio Job Type & Location This is a Contract position based out of South Portland, ME. Pay and Benefits The pay range for this position is $39.00 - $40.00/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) Workplace Type This is a fully onsite position in South Portland,ME. Application Deadline This position is anticipated to close on Jan 20, 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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. 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 due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Keywords: Actalent, Portland , Regulatory Specialist II, Science, Research & Development , South Portland, Maine