Global Regulatory Manager – Contract

This is a fully remote position, open to applicants in Oregon.

📋 Description

• Oversee the formulation and execution of regulatory strategies and plans to ensure the prompt launch of new products and the preparation/review of international regulatory submissions (EU MDR Tech File, Health Canada submission, Saudi FDA, etc).

• Advocate for international regulatory considerations within cross-functional project teams for both new and existing products.

• Review and sanction labeling requirements for global markets; including translation materials, claims assessments, IFU, etc.

• Assess change proposals for their international regulatory implications.

• Foster effective communication within the RA/QA group and among cross-functional business partners such as Product Development, Marketing, Legal, etc.

• Assist the Regulatory and Quality Departments in sustaining ISO 13485 and MDSAP Certifications (internal audits, NB audits, SOP compliance, etc).

• May directly supervise individuals as needed.

⛳️ Requirements

• Bachelor's degree in Science, Engineering, Pharmaceutical disciplines.

• Direct experience in international regulatory affairs (submissions, license renewals, TF, etc.).

• At least 3 years of experience in a medical device, pharmaceutical, or comparable organization.

• Ability to manage competing priorities and meet deadlines.

• Highly organized and detail-oriented with exceptional attention to detail.

• Capable of working independently as well as collaboratively within teams.

• Results-driven, inventive, and able to handle multiple tasks simultaneously.

• Excellent verbal and written communication skills.

• Ability to thrive in a fast-paced environment where requirements and priorities are in constant flux.

• Strong consumer-focused approach and understanding.

• Proficient in managing multiple projects concurrently with robust organizational skills.

• Proactive; capable of working autonomously while also being a collaborative team member.

🏝️ Benefits

• Comprehensive medical, vision, and dental plan options.

• Employer-paid life insurance.

• Supplemental insurance options including Accident Insurance, Short-Term Disability and Long-Term Disability, Cancer Coverage, and more.

• FSA & HSA options available.

• 401k matching up to 4% with immediate vesting.

• Generous paid time off program including elective PTO days, federal holidays, sick/wellness days, floating holidays, and a birthday day off!

• Pregnancy and parental leave.

• Weekly wellness programming in-office.

• Dog-friendly office policy - feel free to bring your furry friend to work!

• Opportunities for learning and development, fostering both professional and personal growth.

• Company-wide events & outings that emphasize team engagement, including small department-specific team-building activities and our annual Fam Jam family carnival celebrating the people who support you in being your best at work. We also organize an annual Day of Service to give back to our local Miami community and offer various volunteer opportunities throughout the year aligned with our mission to support parents and children.

• Exclusive employee product discounts.