N A Regulatory Affairs Manager - Mativ

Our Regulatory Affairs Manager (North America) supports Mativ’s Sustainability & Adhesive Solutions segment (Healthcare & Wellness). This individual will provide cross-functional guidance and support to the US Healthcare & Wellness sites on Regulatory Affairs matters whilst also working collaboratively with other Regulatory personnel within Healthcare & Wellness to support best practices on a global level. This is an exciting opportunity to serve as the primary regulatory resource for US sites, ensuring compliance with all manufactured medical devices, cosmetics, and OTC drugs. The location of this role is Knoxville, Tennessee (hybrid working is supported), although frequent travel to other US sites will be required. This position will report directly to the Global Quality & Regulatory Manager, Healthcare & Wellness. 

•    Provide Regulatory support, guidance, and input for base business, line extensions, and new product development activities, ensuring US and other international Regulatory requirements are incorporated as part of these activities 

•    Prepare global Regulatory strategies or pathways for medical and regulated products to market 

•    Manage Regulatory submissions and 510(k) Submissions to the FDA, in addition to supporting international Regulatory submissions in various countries outside of the US 

•    Engage with Internal Functional Departments, Customers, Certification Bodies, and Regulatory Authorities (as applicable) on Regulatory matters

•    Perform reviews of QMS documentation, including (but not limited to) Customer Complaints, Change Controls, and Quality Agreements to ensure Regulatory requirements are met, taking appropriate action (as required)   

•    Compile materials in a timely manner for license renewals, updates, and registrations 

•    Maintain Regulatory files and databases. Establish and maintain a system for tracking changes in documents submitted to Regulatory agencies or partners.  

•    Review labeling (label, IFUs, manuals, patient guides, etc.) of all medical and regulated products for compliance with Regulatory requirements

•    Participate in Certification Body Audits and Regulatory Agency Inspections, acting as Subject Matter Expert on Regulatory Affairs 

•    Participate in design teams and projects by providing Regulatory guidance throughout the product/process design and development cycle to ensure US and other international Regulatory requirements are incorporated as part of the process. 

•    Provide input on, and review protocols and reports, for design verification and validation relating to material, process and facilities changes, shelf-life, material qualification and safety testing. 

•    Maintain up-to-date awareness of changes within the Regulatory industry, interpreting requirements, sharing knowledge and taking actions necessary to keep the US sites in compliance with Regulatory developments

•    Develop and maintain up-to-date Standard Operating Procedures and Work Instructions for the Regulatory function

•    Drive continuous improvement initiatives for Regulatory, leading, and supporting associated projects 

•    Identifying Regulatory training needs for self, colleagues, and US sites: proactively take steps to organize/deliver identified training opportunities

 

Required
•    Bachelor’s degree in science (preferably chemistry) or equivalent
•    At least 5+ years of experience working within Regulatory Affairs, preferably gained within the medical device and/or pharmaceutical industry 
•    Experience filing submissions for medical devices in the US and international markets
•    Experience of medical devices, OTC drugs, and cosmetics registrations
•    Knowledge of ISO 13485 and ISO 9001
•    Knowledge of 21 CFR 820 – Quality System Regulation
•    Knowledge of 21 CFR 210 & 211 cGMP in Manufacturing, Processing, Packing, or Holding of Drugs and Finished Pharmaceuticals
•    Knowledge of MoCRA Requirements 
•    Front room experience of FDA Inspections and Certification Body Audits
•    Travel approximately 40 %

Preferred
•    Knowledge of ISO 10993 standards 
•    Knowledge of ISO 14971 standard 
•    Understanding of the requirements for stability study programs
•    Certified Lead Audit qualification 
•    Experience of preparing Safety Data Sheets (SDS)
•    Knowledge of REACH and California Proposition 65 

 

Competencies
•    Excellent verbal and written communication skills
•    Good attention to detail

•    Good analytical skills
•    Highly organized and diligent 
•    Works collaboratively within and across teams 

 

As a Mativ employee, you’ll have access to a variety of benefit programs designed to help you no matter your stage of life. 
•    Medical, dental and vision insurance
•    Consumer-Driven Health Plan (CDHP)
•    Preferred Provider Organization (PPO)
•    Exclusive Provider Organization (EPO)
•    Company-paid basic life insurance and Additional voluntary life coverage
•    Paid vacation and competitive personal time off
•    401(k) savings plan with company match
•    Employee assistance programs – available 24/7 to you and your family
•    Wellness and Work Life Support - career development and educational assistance

Mativ Holdings, Inc. is a global leader in specialty materials headquartered in Alpharetta, Georgia. The company makes material impacts on the world every day through a wide range of critical components and engineered solutions that solve our customers’ most complex challenges. We manufacture on three continents and generate sales in nearly 100 countries through our family of business-to-business and consumer product brands. The company’s two segments, Filtration & Advanced Materials and Sustainable & Adhesive Solutions, target premium applications across diversified and growing end-markets, from filtration to healthcare to sustainable packaging and more. Our broad portfolio of technologies combines polymers, fibers, and resins to optimize the performance of our customers’ products across multiple stages of the value chain. Our leading positions are a testament to our best-in-class global manufacturing, supply chain, and materials science capabilities. We drive innovation and enhance performance, finding potential in the impossible.

 

Mativ and its subsidiaries are Equal Opportunity Employers. Qualified applicants will be considered without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.