Job Title : Regulatory Affairs Specialist III Job Location : Hyderabad India Engineering Centre is a Global R&D centre which provides Product development services to the Global Business units. Our Product development ranges from Laboratory equipment's, Analytical instruments, remote monitoring solutions, Chromatography & Mass spectrometry. Role Description : This is a Divisional role as one of the Regulatory Affairs core team members supporting both manufactured and OEM products for the Business Unit (BU). The Regulatory Affairs (RA) Specialist is responsible for facilitating and executing regulatory strategy defined by the business unit RA leadership. This position assists customers by providing regulatory support as it applies to the use of business unit products and services. The RA specialist will ensure adherence to established processes, policies, and procedures of the company and external regulatory agencies Responsibilities : 1) Responsible for the coordination and implementation of the LPDs regulatory strategy and compliance programs, of the assigned Business Unit, through the review, consultation, training, and support of each discipline (Engineering, Operations, Quality, Sales, Sourcing, etc) to fulfill their business goals in a compliant manner.
2) Responsible for supporting a Regulatory Affairs network of people and resources in the business unit to provide general regulatory support in the regions and time zones where BU facilities operate, also, provide additional review and consultation for more detailed regulatory needs from centers of compliance excellence.
3) Responsible for providing regulatory assistance in executing NPD and complex POE projects (Complexity Level L3 and above), monitor and manage timelines in RA control, and provide a regular update to project stakeholders.
4) Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions
5) Liaise between the respective disciplines and 3rd Party regulatory agencies (UL, CSA, TUV, Notified Bodies, FDA, ISO registrars, etc) and ensures this interaction follows the established best practice model for the division.
6) Responsible for execution of Class II (and above) medical device product registrations in various countries/geographies interfacing with the cross-functional teams (Engineering, Operations, Quality, Sales & Registration Agents )
7) Should have a working knowledge of and eagerness to expand knowledge of the applicable standards and regulations that apply to products (Safety, EMC, Wireless, RoHS, REACH, Fgas, etc), filter and disseminate applicable information to the respective disciplines internally and the regulatory agencies for a consistent compliance approach
8) Provides a review of regulatory agency communications (e.g. FDA, EU Competent Authorities, China SFDA, etc)
7) Assist in RA SOP development and adhere to internal audit requirements per QMS
8) Participates in risk-benefit analysis for regulatory compliance
9) Identify, plan and implement process improvement initaitives Qualification : 1. Graduate degree in Science or Engineering
2. 8-13 years of experience in regulatory affairs of Laboratory products / medical device or any other regulated industry
3. Shall have a minimum of 5 years of experience in global regulatory requirements of product, processes, and procedures.
4. Experience in product compliance or product stewardship 3-5 years either in industry or at a Nationally Recognized Test Lab will be an added advantage
5. Working knowledge of the applicable product safety standards and how to apply them effectively
6. Regulatory Affairs Certification (RAPS) and knowledge in GxP's(GCP, GLP & GMP) would be an added advantage Skills, Knowledge and Experience :

• Able to work independently without supervision
• Able to communicate effectively, written, and oral, with both technical and non-technical colleagues.
• Self-Motivator, Does not accept waiting for a response. Must work with respective stakeholder to obtain the necessary information and drive a project forward
• Must be a Problem Solver; Identifies problems and reviews related information to develop and evaluate options and implement solutions.
• Able to manage parallel projects and sometimes competing deliverables to meet project delivery dates.
• A team player willing to support and guide peers in analyzing and solving challenges
• Working knowledge of the application of FDA and ISO quality standards in the industry
• Experience with initial regulatory submissions as well as periodic submission of updates (examples include FDA 510(k) submissions, MDD / IVDD Technical Files, etc.) a plus.
• Should have a working knowledge of and eagerness to expand knowledge of the applicable standards and regulations that apply to products (Safety, EMC, Wireless, RoHS, REACH, Fgas, Prop65, etc.), filter and disseminate applicable information to the respective disciplines internally, and the regulatory agencies for a consistent compliance approach

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