Regulatory Affairs Specialist

About the Role

HCLTech is seeking a dedicated and driven Regulatory Affairs Specialist to contribute to advancing technology through innovative and creative efforts. This full-time position is located in Raynham, MA. The specialist will play a crucial role in providing regulatory guidance and ensuring compliance during the product development lifecycle, facilitating smooth market launches across global regions.

Key Responsibilities

• Offer strategic regulatory insights to product development teams regarding regulatory pathways, pre-marketing processes, and necessary submissions to ensure efficient timelines for product modifications.
• Manage submissions for licenses and authorizations related to existing product maintenance, international registrations, and dossiers, including Change Notifications, Technical Documents, and communication with Notified Bodies.
• Ensure that product development aligns with relevant regulatory standards, providing support for claims, labeling content, and promotional material compliance.
• Identify required data and information to satisfy regulatory approval processes.
• Develop and approve labeling specifications, packaging, advertising, and promotional content based on regulatory standards.
• Support Regulatory Affairs during internal and external audits.
• Plan and monitor the timeline for regulatory submission documentation through project completion.
• Contribute to enhancing and optimizing Regulatory Affairs processes and practices.
• Act as the Regulatory Affairs representative within cross-functional project teams, advising on US and international regulatory matters, including for Purchased for Resale products.
• Collaborate with other departments to generate necessary data for regulatory submissions.
• Review and approve regulatory authorizations pertaining to product and procedural changes.
• Respond to inquiries from foreign governments and distributors by preparing and submitting necessary documentation for international marketing approvals, and regularly provide regulatory updates to associates and affiliates.

Compensation and Benefits

The hourly wage for this role ranges from $50 to $55, varying based on location, expertise, experience, education, and other legal factors. Eligible candidates may receive performance-related bonuses in line with company policy. Benefits include medical, dental, vision, pharmacy coverage, life insurance, accidental death & dismemberment, disability insurance, employee assistance programs, a 401(k) retirement plan, 10 days of paid time off annually (with some eligibility for flexible need-based leave), and 10 paid holidays per year.

Equal Employment Opportunity

HCLTech is an equal opportunity employer committed to nondiscriminatory employment practices regardless of race, religion, gender, color, age, national origin, pregnancy status, sexual orientation, disability, genetic information, military or veteran status, or other protected categories. Concerns related to hiring discrimination can be reported for investigation.

Professional Development

The company encourages continuous personal and professional growth, offering transparent communication with leadership, career development programs at all stages, opportunities to experiment with various roles or industries, and an environment empowering employees to control and explore their career paths.