Regulatory Affairs Manager - USA

About Us:
How many companies can say they’ve been in business for over 177 years?!
Here at ZEISS, we certainly can! As the pioneers of science, ZEISS handles the everchanging environments in a fast-paced world, meeting it with cutting edge of technologies and continuous advancements. ZEISS believes that innovation and technology are the key to a sustainable future and solutions for global change. We have a diverse range of portfolios throughout the ZEISS family in segments like, Industrial Quality & Research, Medical Technology, Consumer Markets and Semiconductor Manufacturing Technology. We are a global company with over 42,000 employees and have over 4,000 in the US and Canada alone! Make a difference, come join the team!

Location/Region: This position can be located anywhere in the US.

What’s the role?

We are looking for a USA Regulatory Affairs Manager to proactively lead and
manage regulatory compliance for various initiatives related to vision care in the US. This role will focus on coordinating with internal and external parties and stakeholders to ensure our new business ventures meet all regulatory
requirements within the market.

Sound Interesting?
Here’s what you’ll do:

• Strategy & Process Ownership: Analyze regulatory compliance for new and existing products and business initiatives for medicines/drugs, medical devices, and food supplements. Assess regulatory requirements by channel to ensure optimum marketability. Develop and design internal and external processes and product requirements. Collaborate with external partners (suppliers and regulatory agencies) for regulatory assessments and regulatory strategy development for new products.
• Project Coordination: Collaborate with cross-functional teams to offer regulatory guidance throughout the product lifecycle. Conduct regulatory review and approval of key documents before stage approvals.
• Risk Management & Process Compliance: Identify regulatory risks associated with initiatives and collaborate with stakeholders to develop effective mitigation strategies for pre and post-launch (i.e., post-market surveillance/pharmacovigilance). Work with quality teams to ensure products and suppliers meet all regulatory and company requirements.
• Submission Coordination: Lead internal teams and external parties to ensure timely and accurate local regulatory submissions.
• Stakeholder Management & Insights: Cultivate relationships with regulatory agencies, industry associations, and external stakeholders to stay up to date on compliance topics and address regulatory challenges. Monitor global regulatory trends related to new business areas to inform initiatives.
• Regulatory Review and Approval of Product Labelling and Advertising: Ensure products meet regulatory requirements for the US market for all product categories. Proactively work to ensure all claims are compliant with relevant regulations and are kept up to date with any changes in the rules.
  
  

Do you qualify?

• Education: Bachelor’s degree in law, Engineering, Technology, Life Sciences,
• or a related field. Master’s degree preferred.
• Experience: 10-15 years in regulatory affairs for OTC medicines/drugs;
• Ideally in OTC eye drops, additional medical device and food supplements
• experience is a plus.
•  Knowledge: Strong understanding of regulatory frameworks in the United
• States (e.g., FDA, MOCRA) and relevant industry standards.
• Portfolio Management: Experience in managing several parallel projects
• across different categories and functional areas.
   
  
  

We have amazing benefits to support you as an employee at ZEISS!

• Medical
• Vision
• Dental
• RSP
• Employee Assistance Program
• Paid time off including vacation, personal, and sick days
• The list goes on! 
  
  

The annual pay range for this position is $116,000- $145,000.

The pay offered for this role may be influenced by factors such as job location, scope of role, qualifications, education, experience, & complexity/specialization/scarcity of talent.

This position is eligible for a Performance Bonus.

ZEISS also offers robust benefits, including medical plans, retirement savings plan and paid time off.

ZEISS is an equal opportunity employer.

Your ZEISS Recruiting Team:

Lindsay Walker

Zeiss provides Equal Employment Opportunity without unlawful regard to an Applicants race, color, religion, creed, sex, gender, marital status, age, national origin or ancestry, physical or mental disability, medical condition, military or veteran status, citizen status, sexual orientation, pregnancy (includes childbirth, breastfeeding or related medical condition), genetic predisposition, carrier status, gender expression or identity, including transgender identity, or any other class or characteristic protected by federal, state, or local law of the employee (or the people with whom the employee associates, including relatives and friends).