Regulatory Affairs Manager

Pride Global; Tucson (AZ); On-site; USD 104,000 - 114,000; Full time

Job summary

Pride Global is seeking a Regulatory Affairs Manager near Tucson, AZ to lead regulatory submissions and global registration strategies. The role requires coordinating with internal teams and external stakeholders to ensure compliance across lifecycle activities.

The candidate will drive accelerated approvals, manage complex projects, and mentor team members in regulatory best practices. Onsite position with a competitive hourly pay rate and 12-month contract duration.

Qualifications

• PhD in IVDs/Medical with 3–5 years of experience
• Master’s degree in IVDs/Medical with 5–7 years or Bachelor’s with 6–8 years
• Hands-on FDA submissions for medical device software/instrumentation/IVD products
• Strong stakeholder management, communication and conflict resolution skills
• Experience managing complex/global regulatory projects
• Knowledge of US/EU/China/regulatory requirements a plus

Responsibilities

• Lead complex regulatory submissions and global registration strategies.
• Manage regulatory compliance and product lifecycle activities.
• Develop strategies to accelerate global approvals and resolve regulatory challenges.
• Collaborate with internal teams and external regulatory stakeholders.
• Identify risks and provide effective, timely regulatory solutions.
• Mentor team members and promote process improvements and new technologies.

Skills

Regulatory affairs

FDA submissions

Global registration

Stakeholder management

Project management

Regulatory strategy

Education

PhD in IVDs/Medical

Master’s in IVDs/Medical

Bachelor’s in IVDs/Medical

Job description

Russell Tobin is partnering with a biotechnology company to identify a Regulatory Affairs Manager for an opportunity near Tucson, AZ.

Key Responsibilities:

• Lead complex regulatory submissions and global registration strategies.
• Manage regulatory compliance and product lifecycle activities.
• Develop strategies to accelerate global approvals and resolve regulatory challenges.
• Collaborate with internal teams and external regulatory stakeholders.
• Identify risks and provide effective, timely regulatory solutions.
• Mentor team members and promote process improvements and new technologies.

Requirements:

• 3-5 years' experience with a PhD degree; 5-7 with Master’s degree or 6-8 years with Bachelor’s degree in the field of IVDs/Medical
• Hands-on experience with FDA submissions for medical device software, instrumentation, biotech, or IVD products.
• Strong stakeholder management, communication, and conflict-resolutio[n?]ion skills.
• Experience managing complex and/or global projects.
• Knowledge of U.S., European, China, and international regulatory requirements is a plus.

Additional Details:

• Location model: Tucson, AZ (Onsite)
• Position Type: 12 months contract
• Pay range approved: $50-$55/hr. depending on experience

Equal Employment Opportunity

PrideGlobal and it's 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.

Fair Chance Employment

PrideGlobal and it's 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.

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.

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.