Global Regulatory Manager – Contract

📋 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).

• Act as the representative for international regulatory considerations within cross-functional project teams for both new and existing products.

• Assess and approve labeling requirements for global markets, including translation materials, claims review, and Instructions for Use (IFU).

• Analyze change proposals for their impact on international regulations.

• Foster effective communication within the RA/QA team as well as with cross-functional business partners such as Product Development, Marketing, and Legal.

• Assist Regulatory and Quality Departments in maintaining ISO 13485 and MDSAP Certifications through activities like internal audits, Notified Body audits, and SOP compliance.

• May provide direct supervision to individuals.

⛳️ Requirements

• Bachelor's degree in a Science, Engineering, or Pharmaceutical discipline.

• Direct experience in international regulatory affairs including submissions, license renewals, and Technical Files.

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

• Capability to manage competing priorities and deadlines effectively.

• Highly organized and meticulous, with a strong attention to detail.

• Ability to work independently as well as collaboratively in teams.

• Results-driven, creative, and skilled at multitasking.

• Excellent verbal and written communication skills.

• Competence to thrive in a fast-paced environment where requirements and priorities are frequently changing.

• Strong written and verbal communication abilities.

• Passionate about consumer interests and possess a deep understanding of consumer needs.

• Excellent communicator with robust presentation skills.

• Ability to manage multiple projects simultaneously and exhibit strong organizational capabilities.

• Proactive with the ability to work autonomously as well as collaboratively within a team.

🏝️ Benefits

• Comprehensive medical, vision, and dental plan options.

• Employer-paid life insurance.

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

• Flexible Spending Account (FSA) & Health Savings Account (HSA).

• 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 day off for your birthday!

• Pregnancy and parental leave.

• Weekly wellness programming in-office.

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

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

• Company-wide events and outings aimed at team engagement, from small department-specific team-building activities to our annual Fam Jam family carnival that celebrates your supporters. We also host an annual Day of Service to benefit our local Miami community and offer various volunteer opportunities throughout the year that align with our mission to serve parents and children.

• Exclusive employee product discounts.