Regulatory Affairs Specialist

HCLTech is looking for a highly talented and self- motivated Regulatory Affairs Resource to join it in advancing the technological world through innovation and creativity.

Job Title: Regulatory Affairs Resource

Job ID: 125965

Position Type: Full-time with HCLTech

Location: Raynham, MA

Role/Responsibilities:

Regulatory Affairs Resource Job Description:

• Provide regulatory guidance to product development teams in defining regulatory strategies, pre-marketing, and related submissions to support optimal timelines for modified product launches in the global market.
• Execute on the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers, including, but not limited to Change Notifications, Technical Documents, and correspondence with Notified Bodies.
• Guide conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials.
• Define data and information needed for regulatory approvals.
• Develop labeling specifications and approves proposed labeling, packaging, advertising and promotional materials after evaluating conformance to regulations.
• Provide Regulatory Affairs support during internal and external audits.
• Plan schedules for delivery of supporting documentations required for regulatory submissions on a project and monitors project through completion.
• Assist in the development of improved and efficient processes practices for Regulatory Affairs processes.
• Represent Regulatory Affairs on cross-functional project teams, guiding and supporting product development teams on both US and international issues, including Purchased for Resale products.
• Partner with other functions to define and generate data to assist with regulatory submissions.
• Review and provide regulatory authorization for various changes to product, procedures, etc.
• Respond to requests from foreign governments and/or distributors to prepare and submit documentation for marketing approvals in other countries, as well as provide routine regulatory information to associates and affiliates.

Pay and Benefits

Pay Range Minimum: $50.0 per hour

Pay Range Maximum: $55.00 per hour

HCL is an equal opportunity employer, committed to providing equal employment opportunities to all applicants and employees regardless of race, religion, sex, color, age, national origin, pregnancy, sexual orientation, physical disability or genetic information, military or veteran status, or any other protected classification, in accordance with federal, state, and/or local law. Should any applicant have concerns about discrimination in the hiring process, they should provide a detailed report of those concerns to secure@hcltech.com for investigation.

Compensation and Benefits

A candidate’s pay within the range will depend on their work location, skills, experience, education, and other factors permitted by law. This role may also be eligible for performance-based bonuses subject to company policies. In addition, this role is eligible for the following benefits subject to company policies: medical, dental, vision, pharmacy, life, accidental death & dismemberment, and disability insurance; employee assistance program; 401(k) retirement plan; 10 days of paid time off per year (some positions are eligible for need-based leave with no designated number of leave days per year); and 10 paid holidays per year.

How You’ll Grow

At HCLTech, we offer continuous opportunities for you to find your spark and grow with us. We want you to be happy and satisfied with your role and to really learn what type of work sparks your brilliance the best. Throughout your time with us, we offer transparent communication with senior-level employees, learning and career development programs at every level, and opportunities to experiment in different roles or even pivot industries. We believe that you should be in control of your career with unlimited opportunities to find the role that fits you best.