Regulatory Manager

Job Purpose:

To lead, direct and be responsible for overseeing and ensuring compliance to Regulatory Affairs in both domestic and global markets for all activities at NuFACE. Will develop the Regulatory strategy to support NuFACE’s strategic plans. This role is an important business partner to the marketing and product development teams – helping to enable our long-term roadmap and develop a Regulatory strategy to support NuFACE commercial initiatives. This role will represent NuFACE with regulatory agencies and industry groups. The role will drive regulatory compliance which includes 21 CFR part 11, 801, 803, 806, 807, 810, 814, 820, 821, 830, ISO 13485, ISO 14971, EN 46001/2, ISO 60601, ISO 22716, and other global regulations such that mandated processes are created, implemented, and validated consistently across NuFACE and internal/external business entities.

Essential Functions:

• Lead and Direct the Regulatory activities
• Develop strategies and timelines that support commercial plans for the global commercialization of medical devices and cosmetics. Working effectively in a team environment to ensure not only individual tasks are accomplished, but that team and department objectives are achieved
• Brainstorms regulatory strategy with internal and external business partners to develop options for resolving complex and difficult issues to help achieve desired outcomes
• Working with the product development team, craft regulatory submissions are required to obtain premarket approval for products in all countries in which products are to be sold. Prepares510(k)s, and dossiers for international product registrations and approvals. Interfaces directly with outside international distributors, governmental regulatory personnel, including scientific reviewers, administrative staff, and management to facilitate the review and approval of regulatory applications
• Ability to appropriately interpret existing and emerging regulations, standards or guidance documents including potential impact on regulatory and quality function
• Remain current on developments in international standards, regulatory requirements, and industry trends. Works closely with internal teams to establish and implement regulatory policies and procedures to assure compliance with applicable regulations
• Support the review and approval of assigned product labeling, advertising, and promotional materials, to ensure compliance with all applicable FDA and other relevant regulations and industry guidelines.
• Review and interpret scientific literature and summarize effectively in writing. Partner with marketing to help develop and support clinical work and evaluate product efficacy requirements and results
• Independently review changes in products, product specifications, and manufacturing processes to assess regulatory implications of the change

Skills/Qualifications:

• Bachelor’s degree in a engineering or related field
• 6 plus years of management experience in Medical Devices
• Clinical knowledge in dermatology and general medicine or a background in electrical engineering preferred
• Proven leadership and project management skills. Strong Cross departmental communication skills, someone who enjoys working cross functionally, helping to identify important department interfaces, and streamlining processes in a growing and rapidly changing environment
• Cosmetic and Medical Device regulations, Device classification, Medical Device submission and registration requirements. Experience in preparing and filing complete traditional 510(k), Abbreviated, Amendments and Annual Reports to FDA
• Thorough understanding of various medical device/cosmetic/OTC regulatory guidelines/agencies FDA, CDRH, cGMP, ICH guidelines, ISO 13485, ISO 14971, ISO 60601, ISO 22716, 21 CFR part 11, 801, 803, 806, 807, 810, 814, 820, 821, 830. Preferred knowledge of 21CFR210-11, CDER, CFSAN.
• Demonstrated ability to review and interpret International regulatory guidelines as it relates to countries where products are sold
• Familiar with preparing international regulatory registration documents to include but not limited to: product composition formulas, ingredient listings, Quantitative & Qualitative (Q&Q) listings, Certificates of Free Sale (CFS), Certificates of Origin, Certificates of BSE
• Understands global labeling and advertising requirements and restrictions
• Communicates effectively, both orally and in writing. Demonstrates excellent interpersonal skills with personnel at all levels and exhibits a high degree of initiative and motivation
• Demonstrated ability to work independently and produce professional work products
• Strong work ethic and demonstrated ability to deliver assignments on time

Salary : $124,000 - $157,000