Regulatory Affairs Leader (Associate Director)

Location: Marlborough, Massachusetts, United States; willingness to travel up to 10% required.

Company

hirify.global is an IT staffing and IT services company established in 1991, providing talent and technology services to Fortune 500 and mid-size organizations through more than 30 offices.

What you will do

• Lead premarket and postmarket regulatory affairs activities for pharmaceutical or medical products.
• Prepare, maintain, and optimize regulatory submissions, product registration files, renewals, postmarket reports, recall submissions, and authority responses.
• Analyze regulatory changes through regulatory intelligence and implement compliance strategies.
• Coordinate with Product RA, clinical study teams, quality functions, business stakeholders, external reviewers, and regulatory authorities.
• Support inspections, review advertising and promotional materials, and assess adverse events and field actions for local reportability.
• Develop regulatory and quality-system processes while coaching and mentoring other regulatory affairs professionals.

Requirements

• Bachelor’s degree or internationally recognized equivalent plus at least 3 years of pharmaceutical or biotechnology regulatory experience, or at least 7 years of progressive regulatory affairs experience.
• Knowledge and experience applying drug or device regulations to product registration, adverse event reporting, and recalls.
• Strong analytical, problem-solving, negotiation, prioritization, planning, and research skills.
• Ability to work independently and collaboratively, manage deliverables, and use spreadsheet and presentation software.
• Willingness to travel up to 10% of the time.

Nice to have

• IND, NDA, or related submission experience and Regulatory Affairs Certification from RAPS.
• Experience working with FDA, MHLW, Health Canada, KFDA, AAMI, IEC, ISO, or UL.
• Knowledge of Quality Management Systems, adverse event reporting, recalls, orphan drugs, or generics.
• Experience working across cultures, countries, and sites in fast-paced environments.
• Understanding of healthcare-market, commercial, competitive, and political factors affecting regulatory strategies.

Culture & Benefits

• Paid vacation, holidays, and personal days.
• Medical, dental, and vision insurance.
• 401(k) retirement savings plan.
• Life insurance and disability insurance.
• Quality and compliance training with defined completion deadlines.