Sr Regulatory Specialist (New England area or Remote)

Mozarc Medical Holding LLC in; Mansfield (OH); Remote; USD 65,000 - 95,000; Full time

Job summary

An innovative firm is seeking a Senior Regulatory Specialist to drive compliance for medical devices. This role involves developing global regulatory strategies, managing submissions, and collaborating with cross-functional teams to ensure adherence to FDA and EU regulations. Join a company dedicated to improving kidney health technology, where your expertise will directly impact patient outcomes. With a supportive environment and opportunities for growth, this position offers a chance to make a meaningful difference in the lives of kidney patients while advancing your career in a rewarding field.

Benefits

Comprehensive Total Rewards Package

Opportunities for Professional Growth

Community Engagement Initiatives

Qualifications

• 4+ years of regulatory experience in medical devices.
• Strong knowledge of FDA and EU MDR regulations.

Responsibilities

• Develop global regulatory strategies for medical devices.
• Collaborate with teams to ensure compliance throughout product lifecycle.

Skills

Regulatory Strategy Development

Compliance with FDA

Regulatory Submissions

Technical File Management

Cross-Functional Collaboration

Excel Mastery

Knowledge of EU MDR

Education

Bachelor's Degree

Advanced Degree

Tools

Smartsheets

Windchill

Job description

Sr Regulatory Specialist (New England area or Remote) (Project Management)

About Mozarc Medical

At Mozarc Medical, our vision is to reimagine the future of holistic kidney health technology. Established in 2023 out of equal investments from DaVita, a leading provider of kidney care services, and Medtronic, one of the world's largest medical device companies, Mozarc Medical offers an exciting and unique start-up experience backed by the support of two long-time industry and market leaders.

Driven by our mission and values, we put our patients at the center of all we do. Our employees play a key role in developing technology solutions that enrich patients' lives and create meaningful progress in the treatment of kidney disease. Find your purpose and passion at Mozarc Medical.

Position Title: Senior Regulatory Specialist (New England area or Remote)

A Day in the Life

Responsibilities

• Develop and execute global regulatory strategies for new and existing medical devices to ensure compliance with FDA, EU MDR, Health Canada and other global regulatory requirements
• Assess product and process changes, serving as regulatory point of contact on large-scale projects
• Manage both devices and kits, ensuring product complies with all global regulations
• Assist in the review of product labeling, ensuring compliance with materials of concern and international standards
• Review and approve advertising and promotional materials to ensure regulatory compliance
• Collaborate with cross-functional teams, including R&D, Quality, and Marketing, to provide regulatory guidance and support throughout the product lifecycle
• Interact with regulatory authorities and notified bodies
• Assist in the development and maintenance of internal regulatory policies and procedures

Must Have

• Bachelor's degree and minimum of 4 years relevant experience or advanced degree and 2 years of experience

Nice to Have

• In-depth knowledge of FDA, EU MDR, and other global regulatory requirements for medical devices
• Proven experience with regulatory submissions and technical files
• Mastery with Excel; and experience using Smartsheets
• Notary Public
• Prior history with Windchill, is a plus
  

Why Work with Us?

Working here is highly rewarding – we have the privilege of helping kidney patients experience greater freedom, improved outcomes and a renewed passion for life.

It's essential our team members feel valued, supported and empowered too. That's why we provide a comprehensive total rewards package and opportunities to grow, develop and give back to the communities where we live and work – helping you reach your potential and enjoy a career full of life-changing possibilities.

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

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

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