Sr Regulatory Affairs Specialist I

We Make Life More Rewarding and Dignified

Location: Libertyville

Department: Regulatory

Summary:

As an individual contributor, the function of a Senior Regulatory Affairs Specialist collaborates cross functionally on project teams to direct completion of regulatory requirements to assure successful new product registrations, or in support to changes to existing products. The individual will prepare and submit documentation needed for registrations globally. This involves regular high-level analysis and interpretation of government medical device regulation and guidance, strategy development, project management of deliverables and tracking through to completion.

Responsibilities:

• Represent Regulatory Affairs in project teams with assistance on the development of regulatory strategies for new product development and product changes.
• Compile and submit, in a timely and accurate manner, regulatory documents according to regulatory requirements.
• Assists with the preparation, review, and approval of department SOP's.
• Assists with regulatory advice to project teams.
• Respond 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.
• Manage regulatory activities relating to specific portfolio of products/projects (product owner).
• May review labeling and promotional material for compliance with local regulations.
• Maintain annual licenses, registration renewals and listings with various health authorities.
• Participates in the monitoring of proposed regulations on a federal and state level (domestic and international) that affects the viability of Hollister Business.
• Participates in the monitoring of existing and proposed standards (ISO, EN, BSI, etc.) that are applicable to Hollister Business

Requirements:

• Number of relevant years of experience necessary: 5-8.
• Five years in a Regulated industry experience minimum. Higher education may compensate for years of experience.
• 2+years of regulatory experience.
• Bachelor's degree in scientific discipline required, M.S. preferred.

Specialized Skills/Technical Knowledge:

• Possesses good knowledge, and ability to apply understanding, of medical device regulations. This includes but not limited to :
  
  
  
  • US: 21 CFR Part 820
  • Canada: Medical Device Regulations SOR/98-282
  • EU: 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.
• Prolonged sitting, typing and standing.
• Proficiency in English.

#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: 34557