Regulatory Affairs Manager

Essential Functions:

• Product Registrations
• Interacts with internal and external customers, regulatory authorities, both domestic and international, regarding product submissions, change notifications, and where applicable inspections.
• Coordinates and manages the preparation and submission of regulatory document required for product registration in USA, EU, Canada, Australia, Brazil, Japan and other countries as requested.
• Maintains annual facility registrations and product listings for drugs, medical devices, and cosmetics where applicable.
• Works closely with cross-functional teams to gather and compile the necessary data for technical files and product information files.
• Regulatory Compliance
• Acts as a Person Responsible for Regulatory Compliance in accordance with applicable EU Regulations.
• Keeps abreast with the latest relevant regulations, standards, and guidelines and communicates regulatory changes to appropriate departments.
• Collaborate with QA to ensure the quality management system (QMS) complies with relevant regulations and standards.
• Appropriately checks the conformity of the device prior to release and where applicable, issues Declaration of Conformities.
• Oversees activities related to post-market surveillance and vigilance reporting.
• Conducts Internal Auditing
• Assesses the impact of regulatory changes on the company's products and processes and ensures compliance with these requirements.
• Product Development/Commercialization
• Develops and implements regulatory strategies to facilitate the successful introduction and commercialization of regulated products.
• Advise project teams on premarket regulatory requirements.
• Advise on export and labeling requirements.
• Oversees the implementation of risk management processes. Work with cross-functional teams to identify and address potential risks associated with regulated products.
• Coordinates biocompatibility and/or safety evaluations as needed.
• Supervision of Regulatory Staff
• Provides overall regulatory support and guidance to Regulatory Staff and external customers.
• Provide guidance and assign projects/tasks.

Qualifications:

• 5 - 7 years of directly related experience in regulatory affairs.
• Previous experience in leadership role with ability to lead, motivate, and develop a team.
• Ability to interact and communicate/collaborate at all levels internally and externally.
• Demonstrated knowledge of both domestic and international regulations for regulated products, such as medical devices, pharmaceuticals, and/or cosmetics.
• Demonstrated knowledge of current Good Manufacturing Practices (cGMP) and Quality Management Systems (QMS).
• Familiarity with international market labeling and registrations.
• Strong problem solving and multi-tasking skills.
• Strong computer skills
• Excellent writing skills - position requires technical writing/documentation.
• Well organized, articulate, a self-starter, responsive and a team player.
• Bachelor's degree in chemistry or science-related field

Desired:

• Experience with the FDA 510K Submissions and EU MDR
• Microsoft D365 software experience.
• Audit experience
• Training experience
• RAC, or equivalent certificate from a university
• Ability to navigate highly ambiguous situations.