Senior Specialist, Regulatory Affairs

About the role

Join a team that supports regulatory initiatives across the product lifecycle, with a focus on sustaining and environmental regulatory activities to help ensure products remain compliant with applicable global regulatory requirements. This role partners with cross-functional teams to assess regulatory implications, support submission planning, and provide regulatory guidance that informs product and business decisions.

Responsibilities

• Support development, review, and maintenance of regulatory procedures and documentation.
• Contribute to regulatory strategies and recommend updates based on evolving regulations, guidance, and industry standards.
• Assess and support compliance with global regulatory and environmental requirements, evaluating potential impacts of evolving regulations on products, processes, and business activities.
• Provide regulatory input for product development, lifecycle management, and change planning activities.
• Evaluate regulatory requirements and potential impacts for new products, product modifications, and business initiatives.
• Research and assess regulatory history, product classifications, and therapeutic or diagnostic landscapes to identify regulatory pathways and considerations.
• Identify potential regulatory risks, trade-related considerations, and approval challenges, and communicate findings to project teams.
• Define submission, registration, and approval requirements and support preparation of regulatory deliverables.
• Participate in risk-benefit assessments and compare regulatory outcomes against original product concepts to support future recommendations and regulatory planning.

Requirements

• Bachelor's degree required. Preferred in Regulatory Affairs, Engineering, Life Sciences, Biological Sciences, or a related field.
• Minimum 2 years of experience in regulatory affairs within the medical device, biotechnology, pharmaceutical, healthcare industry, or other regulated industries.
• Preferred Qualifications: Experience assessing and supporting compliance with environmental regulations and reporting requirements; Experience supporting products throughout the full product lifecycle, including development, commercialization, and post-market activities; Regulatory Affairs Certification (RAC).

Qualifications

• Master's degree in Regulatory Affairs, Engineering, Life Sciences, or a related discipline.

Benefits

• Health benefits: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program.
• Financial benefits: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance.

Pay

• Pay Ranges: USN: $83,300 - $138,800 USD Annual
  US5: $87,500 - $145,700 USD Annual
  US10: $91,600 - $152,700 USD Annual
  US15: $95,800 - $159,600 USD Annual
  US20: $100,000 - $166,600 USD Annual
  US30: $108,300 - $180,400 USD Annual

Schedule

Strong preference will be given to candidates who reside within a commutable distance of Portage, Michigan and can work a hybrid schedule.