Job Description
JOB DESCRIPTION Position title Regulatory Registration Associate/ Specialist Internal Stakeholders Volk HQ: Quality and Regulatory Department Business Unit Volk Optical Inc (A Halma Company) External stakeholders Distributors, Authorized Representatives, Regulatory Authorities, External Auditors Reports to Quality & Compliance Director Location Bangalore/ Mumbai/ Delhi 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. Headquartered in the UK, it is also one of the top performing businesses in the FTSE index with 13 successive years of record revenues and profits. It has been recognised as Company of the Year 2018 and as one of Britains Most Admired Companies by its peers. For the past 40 years Halmas innovative products have been protecting and improving life for people worldwide. Its companies are based all over the world and they provide innovative solutions to many of the key problems facing the world today, from water security to preventable blindness. Halmas companies and products are diverse, but have a core focus on safety, health, and environmental markets which help save peoples lives every day. Their water monitoring systems protect water networks serving millions of people globally and their fire protection systems protect people in public buildings and offices around the world, including landmarks such as Buckingham Palace, The Shard, and the White House. Their medical devices help spot preventable diseases and restore lost eyesight and their environmental devices help measure air quality in cities and monitor the planet's health from space. Halmas goal is to build on its success and create greater value by growing a safer, cleaner, healthier future for everyone, every day. Halma India is Headquartered in Bengaluru with branch hubs in Mumbai, Delhi, Vadodara and Thanjavur. Halma plc is deeply committed to the India market and continues to expand its investment here. With over 210+ employees and 5 locations in India, Halma India expects to grow rapidly over the next 5 to 10 years. For more info, visit www.halma.in / www.halma.com About Volk Optical Do you want to join a team of hard-working and intelligent people, while having an impact on lives Volk Optical is looking for ambitious people with the spirit of innovation and improvement which are vital characteristics to our success. The four cornerstones of our company culture are achievement, innovation, empowerment, and customer satisfaction. Volk Optical Inc. (www.volk.com) 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 purpose of role in current business/market scenario) 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. The associate will be responsible for maintaining regulatory compliance via registrations, document control, being part of the internal and external audit team, analysing registration data, and streamlining registration activities. In addition, the associate will provide regulatory support to marketing, quality, and production with respect to customer, process, and quality concerns. Responsibilities (KRAs / deliverables / job expectations) 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 by performing research and analysis in both new and sustaining markets. 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 (critical / high impact aspects of role) 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. Be aware of recent and future regulatory trends and plan accordingly to ensure Volks compliance. Ability to develop and evaluate risk of potential regulatory strategies for new and modified products by performing research and analysis in both new and sustaining markets. Must show appropriate judgement and logic to show improvements to the quality system, document control, and regulatory compliance. Key attributes (critical functional competencies) 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 Proficient in project management, and possess initiative and flexibility to see through completion of project objective Ability to interact with multiple departments, including Customer Service, Sales, Production, and Engineering. Demonstrated success and track record as an individual contributor who has delivered on top line results. Academic qualification A Bachelor's degree is required, preferably in Science, Engineering, or Business Experience (exposure) Minimum 7 years of experience. Minimum of 1-2 years regulatory registration/ submission experience is preferred Understanding of applicable FDA and ISO regulations with RAPS/RAC certification is preferred Competencies (fundamental skills and attitudes) Experience of operating in a small but dynamic and fast-moving business environment and enjoys operating with a sense of urgency Be willing and able to operate in a lean environment and be creative and prudent in optimizing workflow Highly collaborative team player with the ability to engage quickly and help leadership Active and effective change agent; thrives in driving change while ensuring flawless execution and delivery 2
