Regulatory Affairs Specialist II

Job Description

About Company: Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com . About Team: Providing best in class product development services to ThermoFisher Scientific Global Business Units, is one of the core functions of the India Engineering Center (IEC). This Global Research and Development Center, established in 2009, is located in Hyderabad, with over 150 employees. We are a team committed to develop innovative and cutting edge technologically advanced products ranging from laboratory equipment, analytical instruments, remote monitoring solutions, chromatography and mass spectrometry. We are proud of the work that we do at the India Engineering Center thereby fulfilling our mission of making the world a healthier, cleaner and safer place. Responsibilities :

• Responsible for the coordination, evaluation and implementation of LPD s regulatory strategy and compliance programs 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.
• Responsible for supporting a Regulatory Affairs network of people and resources in LPD to provide general regulatory support in the regions and time zones where LPD facilities operate with additional review and consultation for more detailed regulatory needs from centers of compliance excellence.
• Supports an effective interface 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.
• Provides review, consultation and support for regulatory agency communications for LPD (e.g. FDA, EU Competent Authorities, China SFDA, etc).
• Should have a detailed knowledge of the applicable standards and regulations that apply to LPD (product safety standards like IEC 61010-1, EMC standards, applicable regulations like the RoHS, REACH and the F-gas regulation etc) so that that RA team can disseminate and filter this information to the respective disciplines inside LPD and the regulatory agencies that LPD works with to establish a consistent compliance approach.
• Participates in product reviews and ensures that the RA team provides a compliance review of each stage gate review for both internal product designs or changes and OEM branding projects.
• Responsible for reducing product liability while driving towards achieving our 20:20 vision of world class product compliance by 2020.
• Must support and help effectively manage any identified non-conformity or product liability discovery or incident as assigned by the RA Support Manager.
• Provides support to customers relative to compliance issues.
• Act as a change agent for improvement initiatives
• Perform all job duties in a safe manner and obey all safety policies and procedures
• Perform as a Role Model Leader, acting in compliance with the Thermo Fisher Code of Ethics and the 4-I Values (Integrity, Intensity, Involvement and Innovation).
• Perform all job duties within ISO standards, regulatory or statutory requirements.

Qualification

• B.E/B. Tech in Electronics/Electrical/Mechanical Engineering

Skills, Knowledge and Experience

• Seven or more years (with Bachelors degree) of experience in Quality/Regulatory compliance (Five years with an advanced degree), experience working in a matrix organizational structure a plus.
• Working knowledge of the application of FDA and ISO quality standards in industry.
• Experience with FDA or Notified Body inspections.
• 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.
• Solid knowledge of the applicable safety standards and how to apply them effectively.
• Experience of negotiating requirements with competent authorities or regulatory bodies a plus.
• Medical Device manufacturing experience preferable.
• Adaptability and flexibility to manage changing demands and handle substantial time pressures
• Solid financial understanding and ability to relate business improvements into relevant financial terms
• Demonstrated experience in problem solving, particularly around managing a new regulation requirement, or risk assessment around a product liability issue.
• Position requires up to 10% overnight and international travel. Required travel may span weekend days and/or holidays. Must have or be able to obtain a valid passport which allows travel to countries in Europe, N. America and S. America and Asia Pacific as required. Requires ability to transport and use common computer and communications equipment while traveling.
• Job duties may require brief exposure to research laboratory biopharmaceutical or pharmaceutical laboratory equipment.
• Proven facilitator that effectively coordinates and leads efforts and input from various internal functional groups, which will result in collective team achievements

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Keyskills :
documentationdatabase administrationdeliveryfunctionalcode of ethicsresearchdevelopmentcontinuous improvement facilitationrole modellife sciencesiso standardsbusiness unitsfdabrandingidentity marketing