Senior Regulatory Affairs Specialist

Overview

The Senior Regulatory Affairs (RA) Specialist supports the regulatory and product registration activities of the company globally including India, the Asia Pacific region, and the Middle East. This RA Specialist role requires a professional who will work closely with high priority regulatory activities such as CDSCO import licences and associated registrations activites in India, and product registration in Australia, Saudi Arabia, the United Arab Emirates, Singapore, Malaysia, the Philippines, and Thailand. The RA Specialist will provide regulatory feedback in order to facilitate the launch of new products in the region and work with the design control teams to assess for regulatory impact of product changes. This RA Specialist will provide technical guidance to cross functional teams for submission preparation and interaction with regulatory agencies, in-country representatives, and distribution partners.

Responsibilities

• Coordinate, author, and prepare regulatory submissions, including CDSCO import licence applications (Form MD-14/MD-15) and registration certificates, Australian TGA ARTG inclusion applications, Saudi FDA Medical Device Marketing Authorization (MDMA) applications, UAE MOHAP registrations, Singapore HSA product registrations, Malaysia MDA registrations, Philippine FDA Certificates of Product Registration, Thai FDA licences, and/or other documentation required for registration/licensure of products across the Asia Pacific and Middle East regions.

• Serve as a strategic business partner with business clients to proactively develop and implement practical, compliant regulatory plans, and delivering timely, effective business solutions to quality and regulatory issues.
• Respond to regulatory agency requests and obtain necessary premarket approvals, registrations, and/or licences from health authorities across the India, Asia Pacific, and Middle East markets.
• Provide general support to the RA/QA department in regulatory-related matters.
• Communicate with external agencies including CDSCO, TGA, SFDA, MOHAP, HSA, MDA, Philippine FDA, Thai FDA, and other health authorities with which the department interacts.
• Manage in-country representatives, authorized representatives, importers, and distributor partners for regulatory matters, including the review of licence holder obligations and appointment documentation.
• Act as regulatory SME in product development cross-functional teams and other cross-functional activities as assigned.
• Evaluate and approve proposed changes to products and controlled documents; develop, approve, and implement regional regulatory action plans based on these changes.
• Maintain regulatory information in Rimsys, regulatory information management system, to ensure product selling status is in regulatory compliance with applicable local and regional country requirements.
• Review and approve labeling for compliance to standards, guidelines, regulations, and regulatory approvals/clearances, including country-specific labeling, language, and import documentation requirements.
• Provide assistance and expertise during regulatoryinspections or audits.
• Create and maintain regulatory documents and records, including summaries of such regulatory affairs activities and reports to management.
• Continue to enhance internal regulatory procedures and processes. Create and revise procedures as needed and provide training for these updates.

• This position requires the ability to take initiative and effectively communicate cross-functionally, both externally and at all levels of the organization, across multiple time zones.Regular working hours with two hours of minimum overlap with the USA team

• Uphold the Company’s core values of Integrity, Innovation, Accountability, and Teamwork.
• Demonstrate behavior consistent with the Company’s Code of Ethics and Conduct.
• It is the responsibility of every Spacelabs Healthcare employee to report to their manager or a member of senior management any quality problems or defects in order for corrective action to be implemented and to avoid the recurrence of the problem.
• Duties may be modified or assigned at any time to meet the needs of the business.Recommend and maintain quality programs and systems to support corporate quality policy, regulatory requirements, and quality objectives.

Qualifications

• Bachelor’s degree required; a technical or engineering discipline is preferred.
• At least eight years of experience in the medical device or a related industry, including at least five years in Regulatory Affairs; SaMD experience is preferred.
• Extensive medical device registration experience in India, Australia, Saudi Arabia, the United Arab Emirates, Singapore, Malaysia, the Philippines, and Thailand.
• Familiarity with the ASEAN Medical Device Directive, IMDRF guidance, and reliance/abridged review pathways that leverage US FDA, EU MDR, and MDSAP approvals is preferred.
• Experience working directly with health authorities, preferably in India and/or the other primary markets.
• Demonstrated success managing regulatory submissions.
• Thorough knowledge of product development best practices and design control.
• Ability to assess regulatory issues and advise on compliant decisions.
• Strong attention to detail, organization, and ability to prioritize multiple projects and tasks.
• Excellent written and verbal communication and negotiation skills for internal and external audiences at all levels; professional fluency in English is required.
• Proficiency with Microsoft Word, Excel, PowerPoint, Teams, and Outlook.
• Working knowledge of product lifecycle management and/or document control systems is preferred.
• Demonstrated track record of encouraging innovation and out-of-the-box thinking.
• Experience in supporting the development of software for use in cloud environments is highly desirable.
• Knowledge of and ability to work within a global corporate environment is required.
• Ability to travel internationally up to 10% and obtain required travel documents.
• Must be able to complete job responsibilities in an environment with global time zone needs, such as attending late-night/early-morning meetings by phone and/or web to meet global business needs.

PHYSICAL REQUIREMENTS:
• Standing: 0%-5%
• Bending: 0%-5%
• Sitting: 70%-75%
• Stooping: 0%-5%
• Reaching: 0%-5%
• Walking: 0%-5%
• Lifting: (0 – 25lbs or 25 – 50lbs) < 5%
• Use of computer: 90%