Join to apply for the Regulatory Registration Specialist role at Halma plc .
About Halma Halma plc is a global group of life-saving technology companies with a clear purpose to grow a safer, cleaner, healthier future for everyone, every day. Halma is a FTSE 100 company and employs over 7,200 people in nearly 50 businesses across 23 countries. For more info, visit / .
About Volk Optical Volk Optical is looking for ambitious people with the spirit of innovation and improvement which are vital characteristics to our success. Volk Optical Inc. ( is a premier designer and US manufacturer of the highest quality portable ophthalmic cameras, lenses, surgical systems and accessories used in diagnosis and treatment of diseases of the eye.
Position Objective The position is responsible and accountable for global regulatory and registration activities. The Regulatory Registration Associate is an integral part of the Quality and Regulatory team.
Responsibilities Performs research, distribution, storage, tracking, and retrieval of relevant information/documents pertinent to the regulatory registrations and submissions. Evaluates the local and international regulatory environment and assists in providing strategies throughout the product lifecycle to resolve potential regulatory issues and questions from regulatory agencies. Authors, reviews, and publishes paper and electronic submissions and communicates with regulatory authorities and government agencies for new and sustaining product registrations or renewals. Communicates with regulatory authorities and/or distributors to prepare and submit documentation for marketing approval in all markets. Develop and evaluate risk of potential regulatory strategies for new and modified products. Provides regulatory information and support for proposed product claims/labelling in local and international markets. Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation. Helps train stakeholders on current and new quality and regulatory requirements to ensure organization-wide compliance. Partner closely with the Product Development and Product Management team to review proposed product changes for impact on regulatory status of the product. Ensure documents and records meet quality standards and maintain onsite and offsite document storage. Analyzes data, tracks and trends quality metrics, and develops solutions as needed for management review. Performs other duties that are reasonably assigned. Critical Success Factors Identify most favourable regulatory routes and pathways to ensure faster and cost-effective registrations. Excellent written and verbal communication skills, and able to effectively manage regulatory authority or auditors intent. Complies with regulatory requirements of the FDA, Health Canada, European Union, Japan, Brazil, Australia, and any other regulations of target markets. Ability to develop and evaluate risk of potential regulatory strategies for new and modified products. Must show appropriate judgement and logic to show improvements to the quality system, document control, and regulatory compliance. Key Attributes Experience in managing distributors, authorized representatives, and regulatory representatives of different regions is an advantage. Excellent written and verbal communication and technical writing skills with strong attention to detail is required. Proficient in Microsoft Office (Outlook, Excel, PowerPoint and Word). Proficient in time management, multitasking, and organizational skills. Ability to interact with multiple departments, including Customer Service, Sales, Production, and Engineering. Academic Qualification A Bachelor's degree is required, preferably in Science, Engineering, or Business.
Experience Minimum 7 years of experience. Minimum of 1-2 years regulatory registration/submission experience is preferred.
Competencies Experience of operating in a small but dynamic and fast-moving business environment. Be willing and able to operate in a lean environment. Highly collaborative team player with the ability to engage quickly and help leadership. Seniority Level Mid-Senior level
Employment Type Full-time
Job Function Administrative
Industries Medical Device
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