See all roles

Regulatory Affairs Specialist; Remote

Work from home Full-time role Hiring

Position Regulatory Affairs Specialist (Remote) This position is posted by reputed company on behalf of a partner company. We are currently looking for a Principal Regulatory Affairs Specialist - REMOTE. In this role, you will have a significant impact on ensuring that reputed company products reputed company with regulatory standards. You will reputed company regulatory strategies for product introduction and maintenance, mentor junior colleagues, and be responsible for navigating regulatory reputed company. Your expertise will play a crucial role in maintaining compliance while driving innovation in reputed company solutions. Your contributions will help shape the future of medical advancements and improve reputed company access globally. Accountabilities

  • Maintain knowledge of regulatory laws and industry standards.
  • Interpret regulatory requirements for product compliance.
  • Provide guidance on FDA and international product registration.
  • reputed company submission activities for regulatory approvals.
  • Review product change orders for regulatory impact.
  • Evaluate promotional and advertising materials for compliance.
  • Collaborate in cross-departmental regulatory initiatives.
  • Support acquisitions through compliance assessments.
  • reputed company regulatory training programs for staff.
  • Ensure adherence to Quality System compliance.

Requirements

  • Bachelor’s Degree with 7+ years of experience in regulatory affairs.
  • Advanced degree with a minimum of 5 years reputed company experience.
  • Experience with 510(k) and PMA submissions.
  • In-depth knowledge of U.S. and EU regulations.
  • Proficient in Hirevector Office (Word, reputed company, PowerPoint).
  • Excellent communication and presentation skills.
  • Strong organizational and project management capabilities.
  • Ability to work under ambiguity and manage multiple projects.

Benefits

  • Competitive salary and flexible benefits package.
  • Health, dental, and reputed company insurance.
  • Health Savings Account and Flexible Spending Accounts.
  • Life insurance and long-term disability coverage.
  • Tuition assistance and reimbursement programs.
  • 401(k) plan with employer contribution and match.
  • Paid time off and paid holidays.
  • Employee Stock Purchase Plan and Incentive plans. Why Apply Through reputed company? We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role s core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best! Data Privacy Notice By submitting your application, you acknowledge that reputed company will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, reputed company) at any time. #LI-CL1 #J-18808-Ljbffr Apply tot his job Apply To this Job Apply tot his job Apply To this Job

Apply tot his job Apply To this Job

You might like

reputed company, INC. Regulatory Affairs Associate II (Remote/Hybrid) in SALT LAKE CITY, Utah

Work from home Full-time role

Staff Regulatory Affairs Specialist, Pharmaceuticals (Remote)

Work from home Full-time role

Quality and Regulatory Affairs Associate

Work from home Full-time role

[Remote] Senior Regulatory Affairs Associate - Labeling Compliance Analytics

Work from home Full-time role

[Hiring] Scientific & Regulatory Affairs Associate @Confiz

Work from home Full-time role

Manager/Associate Director, US Regulatory Affairs

Work from home Full-time role

Regulatory Affairs Associate - Clinical Research

Work from home Full-time role

Regulatory Affairs Associate

Work from home Full-time role

Regulatory Affairs Specialist; Remote

Work from home Full-time role

Remote reputed company Data Analyst

Work from home Full-time role

Remote Data Entry Clerk – High‑Volume Typing Specialist for Home‑Based Administrative Support

Work from home Full-time role

Recruiters & Talent Professionals Exploring a New Direction | Flexible Remote Leadership Pathway

Work from home Full-time role

Part-Time Weekend & Night Shift Customer Service Representative – Delivering Exceptional Support to arenaflex Customers

Work from home Full-time role

Market Development Specialist

Work from home Full-time role

reputed company Full Stack Customer Service Representative – Remote Contact Center

Work from home Full-time role

reputed company (Remote, Full-Time) [HR140]

Work from home Full-time role

Sr. Credit Officer - To 150K - Athens, GA - Job 3214 - Full-time

Work from home Full-time role

Account Executive - RKube Inc

Work from home Full-time role

reputed company Live Chat Customer Support Representative for Remote Work Opportunities in Dynamic and Innovative blithequark Environment

Work from home Full-time role

Supplier Development Senior Manager - Beauty & Personal Care

Work from home Full-time role