Senior RA Specialist I

We Make Life More Rewarding and Dignified

Location: Libertyville

Department: Regulatory

Summary:

The Senior Regulatory Affairs Specialist plays a crucial role in regulatory intelligence. This position involves collaborating cross-functionally to ensure the timely assessment and compliance with new and updated regulations/standards/guidance. Hollister Incorporated operates in a hybrid working environment. This position can be based out of Libertyville, IL or Ballina Ireland.

Responsibilities:

• Regulatory Intelligence

• Regulatory Monitoring: Continuously monitor and analyze regulatory developments, changes, and updates at the local, national, and international levels related to the company's industry.

• Risk Assessment: Assess the potential impact of regulatory changes on the company's products and operations, and identify areas of compliance risk. Perform gap assessments and execute remediation, as applicable.

• Data Collection & Maintenance: Gather, organize, and maintain regulatory information, documents, and records for easy access and reference.

• Cross-Functional Collaboration: Collaborate with various departments, including Clinical, GQRA, R&D, and Operations, to ensure regulatory compliance and provide guidance on regulatory matters.

• Other responsibilities:
  
  
  
  • Assists with the preparation, review, and approval of department SOPs.
  • Assists with regulatory advice to project teams.
  • Assist with responses to regulatory authorities' queries within defined deadlines.
  • Maintain regulatory files in a format consistent with requirements and stored in defined electronic system.
  • Develop and initiate regulatory project plans.
  • Participates as a secondary representative in stakeholder groups (MedTech, AdvaMed)
  • Performs other duties as needed or required.
  
  
  
  

Essential Functions of the Role: Prolonged sitting, typing, and standing

Requirements:

Number of relevant years of experience in regulated industry necessary: 5-8

• 5+ years of regulatory experience
• Bachelor's degree in scientific discipline required, M.S. preferred.

Specialized Skills/Technical Knowledge:

• Proven track record of identifying, planning, and driving continuous improvement is essential.
• Possesses good knowledge, and ability to apply understanding, of medical device regulations. This includes but is not limited to:
  
  
  
  • US: 21 CFR Part 820
  • Canada: Medical Device Regulations SOR/98-282
  • EU: Medical Device Directive 93/42/EEC and Medical Device Regulations (2017/745)
  • Brazil: Classification and Registration Requirements of Medical Product RDC 185/2001 and GMP Requirements for Medical Devices and IVDs RDC 665/2022
  • Japan: Pharmaceutical and Medical Device Act (2014)
  • Australia: Therapeutic Goods (Medical Devices) Regulations 2002
  
  
  
  
• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
• Exercise independent judgment
• Strong written and verbal communication skills
• Knowledge of regulations and design controls
• Developing negotiation skills and problem-solving skills
• Ability to work closely with people at multiple levels of the organization and with persons from different cultural, language, and regional backgrounds to accomplish assigned job responsibilities.
• Technical system skills (e.g., word processing, spreadsheets, databases, online research)
• Ability to manage or lead multiple small projects and deadlines.
• Ability to identify compliance risks and escalate when necessary.
• English fluency
• 10-20% travel

#LI-Hybrid

Our Total Rewards package in aggregate is above market and includes competitive pay, paid time off programs, peer-to-peer recognition, health and life insurance, wellness programs and incentives, generous retirement savings, and a unique Benefit of Employee Share Ownership Program (BESOP).

• The anticipated base pay range for this position is $84,000 - $120,000 yearly. The actual salary varies based on applicant's location, education, experience, skills, abilities, and other legitimate business factors.
• This position is also eligible to participate in the Hollister Corporate Bonus Plan. The Company also provides a unique Benefit of Employee Share Ownership Program (BESOP) program based on earnings and length of service.

• The Company's health and welfare benefits include medical, prescription, dental, vision, spending/savings accounts, disability, company paid (parental and caregiver) leaves, statutory leaves/disability programs, accident, life, wellbeing, education assistance, adoption assistance, and voluntary benefit programs.
• The Company's 401(k) Retirement Savings Plan includes: auto-enrollment, ROTH, vesting and eligible participants "safe harbor" matching contributions.
• The Company's paid time off benefits include: 11 paid holidays, paid vacation based on length of service and exempt/non-exempt status, and sick days based on statutory requirements and/or exempt/non-exempt status.
• The Company's additional benefits include: education assistance and adoption assistance benefit programs.

About Hollister Incorporated

Hollister Incorporated is an independent, employee-owned company that develops, manufactures and markets healthcare products worldwide. The company spearheads the advancement of innovative products for ostomy care, continence care and critical care, and also creates educational support materials for patients and healthcare professionals. Headquartered in Libertyville, Illinois, Hollister has manufacturing and distribution centers on three continents and sells in nearly 80 countries. Hollister is a wholly owned subsidiary of The Firm of John Dickinson Schneider, Inc., and is guided both by its Mission to make life more rewarding and dignified for people who use our products and services, as well as its Vision to grow and prosper as an independent, employee-owned company, and in the process, to become better human beings.

EOE Statement

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Job Req ID: 34499