Regulatory Affairs Specialist
$50 - $90 per hourActalent
Regulatory Affairs Specialist
Actalent is seeking experienced Regulatory Affairs Specialist for medical device manufacturing client.
Required Qualifications:
- 5+ years experience in Regulatory Affairs and medical device regulations.
- Strong understanding and experience with IEC 60601
- Strong understanding of regulatory submissions, including FDA 510k submissions and EU MDR writing.
- Bachelor's degree in sciences or transferrable discipline.
- 5-8 years of relevant experience.
Excellent opportunity to work flexible/remote and very competitive pay!
Job Type & Location: This is a Contract position based out of Jacksonville, FL.
Pay and Benefits: The pay range for this position is $50.00 - $90.00/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)
Application Deadline: This position is anticipated to close on Nov 2, 2026.
Workplace Type: This is a fully remote position.
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.
$87.4k - $131.1k
...extensive, in-house capabilities, which include engineering, regulatory services, material selection and formulation, prototyping,... ...Ingenyx.com Position Summary We are seeking a Regulatory Affairs Specialist to support global regulatory activities for medical devices,...SuggestedFull timeTemporary workFlexible hours- ...winning company that’s helping create meaningful and lasting change in the healthcare industry. Job Summary The Regulatory Affairs Specialist supports international regulatory compliance and market access activities for food supplements. The position evaluates...SuggestedFull timeLocal area
$80k - $90k
...-being of each individual on our team. Who We’re Looking For - Reporting to the Senior Manager, Regulatory , MANSCAPED® is seeking a Regulatory Affairs Specialist to support global regulatory compliance across current and future markets. This role will help ensure...SuggestedFull timeRemote workFlexible hours- ...execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.Job Description• The Regulatory Affairs Operations (RA Ops) submission group is organized to provide submission development support to project teams and the...SuggestedImmediate start
- ...Description: This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S... ...of international product registrations and related regulatory affairs activities, including execution of procedures and systems...SuggestedWork at office
- The Regulatory Affairs Level III (Senior Specialist) position is responsible for global product registrations and ensuring regulatory compliance in the design, manufacturing, and sales of medical devices (including Class I and II devices, software as a medical device, and...
- Job-ID32758545Reference26-01317Remote50% Remote Job Description: Highly experienced Principal Regulatory Affairs Specialist to lead and support global post-market regulatory compliance activities within the Interventional Cardiology and Vascular Therapies Division. This...Remote work
- ...provides flexibility to work 4 days on site and Friday remotely on a weekly basis in Covington, GA. *** Job DescriptionThe Regulatory Affairs Specialist II is responsible for implementation of regulatory strategies including domestic and international submissions and other...Full timeWork at officeRemote workDay shift
- ...439Reference25-02134 Responsibilities: Contributes to the FDA regulatory submission process; may aid in authoring and/or publishing electronic... ...equivalent). A minimum of 3 years' experience in Regulatory Affairs Advanced experience in the areas that may include preparation...Work at office
- ...medical technology or similar. 5+ years of experience in Reg Affairs, QA, R&D, Manufacturing, and/or Project Management within the... ...verbal and written communication skills. Thorough knowledge of policies, practices and procedures related to Regulatory Affairs.
- The Compliance Specialist reports to the Director Legal, Compliance, Privacy & Security (“Director”) and has a key role in supporting the... ...basis.Conduct research and develop written communication on regulatory requirements to ensure ongoing updates upon request. Manage compliance...Contract work
- ...healthcare, developing complete solutions which optimize the urine drainage process in the Acute Care Hospital setting. The Regulatory Affairs Specialist I is responsible for implementation of regulatory strategies including domestic and international submissions and other...Full timeWork at officeRemote workDay shift
- Job-ID31824874Reference26-00210 Responsibilities: The Regulatory Affairs Level III (Senior Specialist) position is responsible for global product registrations and ensuring regulatory compliance in the design, manufacturing, and sales of medical devices (including Class...
$90k - $125k
Alameda, CAGeneral Administration - Regulatory Affairs /External /HybridIn this role, you will work with the team that ensures that Penumbra products are approved for use in countries around the world, thereby helping to bring our life-saving technologies to patients worldwide...Temporary workWork at officeLocal areaWorldwide- Brecksville, OHDescriptionJob Title: Regulatory Affairs SpecialistDepartment: RegulatoryReports To: Director of Regulatory AffairsFLSA Status: ExemptSupervise the work of others: NoPosition Summary:This position is responsible for preparing submissions to various regulatory...Work experience placementWork at office
- ...international medical device manufacturer has an exciting career opportunity for a highly talented and well-experienced Regulatory Affairs Specialist with FDA experience who will report directly into the Regulatory Affairs Manager. Essential Functions and Responsibilities...Work experience placementLocal area
- Job-ID31525652Reference25-04486 Responsibilities: The Regulatory Affairs Specialist is responsible for working with cross-functional teams to bring IVD (In-Vitro Diagnostic), Research (RUO) and Laboratorial products to market and support activities related to Quality...
- ...financial flexibility by offering contingent labor as a variable cost.Job DescriptionThis individual will be part of the Global Regulatory Affairs team and assists with planning, writing, compilation, and editing of periodic regulatory reports (i.e. DSURs, orphan annual...Work at officeImmediate start
- ...is working in the CMC area. Relevant experience is requiredExperience: 3 to 6 yearsExperience with drug/biologics licensurePrior regulatory experienceTechnical writing experience (CMC experience )Scientific background,Required Skills:CMC/ Regulatory writing experienceScientific...Work at officeImmediate start
- The Regulatory Affairs Specialist 3 develops and executes regulatory strategy and integrates regulatory requirements throughout the product lifecycle. Relies on extensive experience and judgment to plan, create, develop and maintain materials needed for regulatory compliance...
- ...both internal and external cross-functional project teams.• The Regulatory CMC Technical Associate may be called upon to author technical... ...Master s Degree a plus• 4+ years of pharmaceutical regulatory affairs experience• Strong knowledge of NDA, ANDA, MAA, BLA, CTA, or...Work at officeLocal areaImmediate start
- ...Managing the promotional review process, the full-time Regulatory Affairs Specialist will coordinate the review and approval of promotional materials, serve as a liaison for internal and external stakeholders, and ensure compliance with regulatory standards in a remote...Full timeRemote work
- ...Job Description Job Description Regulatory Affairs Specialist Job Description Who We Are: Marketlab is a market leading healthcare solutions organization specializing in the design, manufacturing, and sourcing of private label products. It’s our mission...Temporary workWork at office
$38 - $56 per hour
...LHH Recruitment Solutions is seeking a Regulatory Affairs Specialist for a minimum 6-month remote contract opportunity. This position is open to candidates residing in California who have prior experience in the medical device industry. The ideal candidate will have a...Hourly payContract workLocal areaImmediate startRemote workMonday to Friday- ...Regulatory Affairs Specialist Job Type: Full time - Permanent Location: Madison, New Jersey (On-site) A commercial-stage transplant technology company, part of a global medtech group, is changing how donor organs are preserved and assessed before transplant. Their...Permanent employmentFull time
$80k - $100k
...Regulatory Affairs SpecialistAre you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology... ...an impact in the lives of others.The Regulatory Affairs Specialist is responsible for obtaining domestic and internal...Work experience placementWorldwide- ...making an impact in the lives of others. Learn about the Danaher Business System which makes everything possible. The _ Regulatory Affairs Specialist _ is responsible for obtaining and documenting our mission-critical, Indian regulatory clearances for Masimo’s amazing innovative...Work experience placementLocal areaRemote workWork from homeFlexible hours
- ...Regulatory Affairs Specialist (3-5) Location: Remote/Indianapolis, IN Duration: 19 Months Qualifications: ~3+ years of experience in a CMC/Chemistry Manufacturing and Controls position (regulatory document experience) OR 3+ years Module 3 experience (regulatory...Work at officeRemote work
- ...Regulatory Affairs Specialist IIILocation: Bridgewater, NJ Duration: 9 MonthsManager will consider candidates to be based in either Bridgewater, New Jersey or Cambridge, Massachusetts. Please specify on resume which location candidate is being submitted for.Preparing,...Worldwide
- ...Regulatory Affairs SpecialistRegulatory Affairs Specialist manages assigned projects of moderate complexity which include international regulatory activities; on-market compliance reports or assessment of design changes, manufacturing process and labeling changes for...
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Regulatory Affairs Specialist. Be the first to apply!
- legal compliance analyst United States
- trade compliance specialist United States
- entry level compliance officer United States
- junior compliance analyst United States
- tax compliance analyst United States
- associate director regulatory affairs cmc United States
- hr compliance coordinator United States
- regulatory affairs consultant United States
- international trade compliance analyst United States
- coding compliance specialist United States



