Regulatory Affairs Specialist

Description

Review labeling, training, and promotional material

Support product and shipping release.

Maintenance of FDA’s GUDID database

Technical file update and reviews

Review of External Standards

Support business with government queries and registration documentation requirements.

Review Change Orders and assess regulatory impact of product changes on US and/or International regulatory strategy and submissions

Support post market regulatory compliance activities for US/International product approvals

Assist with the development and maintenance of regulatory affairs department procedures

Comply with applicable FDA and international regulatory laws/standards

Ensure relevant ISO and FDA Export requirements are met, as required

Performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.

Compiles all materials to support submissions, license renewal and annual registrations.

Keeps abreast of regulatory procedures and changes.

Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for new products

Customer Service Support

Proactively drive activities to meet and/or exceed company objectives.

Maintain regulatory files/database and chronologies in good order.

Manage interactions with distributors, consultants, and/or partners.

Perform other related duties and responsibilities as assigned.

Additional Skills & Qualifications

Ability to perform at high levels in a thriving environment, preferably in the medical device industry or combination products industry.

Knowledge of FDA, MDD, EU MDR

Knowledge of Pharma is a plus and ISO regulations/standards, including ISO 10993 (requirements for biocompatibility).

RAC certification is a plus.

Ability to focus and achieve scheduled milestones, including contingency planning.

Strong verbal and written communications with the ability to effectively communicate at multiple levels in the organization.

Strong teamwork and organizational skills with a drive to complete tasks in the face of obstacles and time constraints, and a willingness to collaborate wherever needed.

Job Type & Location

This is a Permanent position based out of Huntersville, NC.

Pay and Benefits

The pay range for this position is $80000.00 - $90000.00/yr.

Benefits provided directly through Safeguard

Workplace Type

This is a fully onsite position in Huntersville,NC.

Application Deadline

This position is anticipated to close on Jul 31, 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.