Regulatory Affairs Specialist

Russell Tobin; EE. UU.; A distancia; USD 39.000 - 41.000; Jornada completa

Descripción de la vacante

Russell Tobin is partnering with a top medical device organization to identify a Regulatory/Environmental Specialist for a REMOTE opportunity in the United States. The role focuses on country registrations, labeling changes, and collaboration with the international regulatory affairs group to support the spinoff strategy.

Responsibilities include creating and updating RegDesk tracking records, ensuring compliance, and supporting documentation.

Formación

• Bachelor's degree or higher in biology, chemistry, pharmacology or related field.

Responsabilidades

• Significant impact on country registrations and labeling changes for medical devices (and some drug products).
• Collaborate with international regulatory affairs group to register products globally based on spinoff strategy.
• Create, maintain and update RegDesk tracking records for the rebranding project.
• Perform additional tasks assigned.

Conocimientos

Attention to detail

Critical thinking

Time management

Compliance document creation

Product assessment

Flexible hours

Educación

Bachelor's degree or higher in biology, chemistry, pharmacology, biochemistry, or related field

Herramientas

Microsoft Office (Excel, Word)

Descripción del empleo

Russell Tobin is partnering with a top medical device organization to identify a Regulatory/Environmental Specialist for a REMOTE opportunity.

Responsibilities:

• The role will have a significant impact on country registrations and labelling changes that are needed for medical devices, and some drug products.
• The position will work with the international regulatory affairs group to ensure products are registered globally based on the spinoff strategy.
• Create, maintain and update RegDesk tracking records for the rebranding project
• Perform additional tasks assigned

Requirements:

• Bachelor's Degree or higher from an accredited university in a technical field such as Biology, Chemistry, Pharmacology, Biochemistry, etc.
• 1 year minimum in regulatory affairs in the medical device industry
• Experience supporting international registrations
• Proficiency with Microsoft Office applications, including Excel and Word
• Qualifications that will help you succeed in this role include:
• Attention to detail: Meticulously evaluate information and ensure compliance.
• Critical thinking: Assess products and substances, understand regulations, and solve problems.
• Time management: Meeting deadlines in this role is critical.
• Compliance document creation: Preparing necessary compliance documents.
• Product assessment: Evaluating products and labelling.
• flexible hours

Pay rate: $28-$30/hr. depending on experience

Accommodations

We are committed to providing reasonable accommodations to applicants and employees with disabilities. If you require a reasonable accommodation to participate in the application or interview process, or to perform the essential functions of this role, please contact us.

For workers in the United States, PrideGlobal and its affiliates offers eligible employee's comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), 401(k)-retirement savings, life & disability insurance, an employee assistance program, legal support, pet insurance and employee discounts with preferred vendors.

PrideGlobal and its affiliates are an equal opportunity employer. We do not discriminate on the basis of the race, religious creed, color, national origin, ancestry, physical disability, mental disability, reproductive health decision making, medical condition, genetic information, marital status, sex, gender, gender identity, gender expression, age, sexual orientation, veteran or military status, or any other characteristic protected by applicable federal, state, or local law.

PrideGlobal and its affiliates are a Fair Chance employer. We consider all qualified applicants, including those with criminal histories, in a manner consistent with applicable state and local Fair Chance laws and ordinances, including, the California Fair Chance Act and all applicable local Fair Chance ordinances.

Only applicable for San Francisco Candidates: Under the San Francisco Lactation in the Workplace Ordinance, we will provide written notice of lactation accommodation rights, and this notice will automatically be given upon hiring, any inquiry of parental leave or lactation accommodation.

Only applicable for Kentucky positions: For this type of employment, state law requires a criminal record check as a condition of employment. This applies to direct care staff (Examples: RN, LPN, Nurse Aides, Therapists) referred to Kentucky nursing facilities, assisted living communities, or long-term care facilities, in accordance with KRS 216.793.