Regional QARA Manager (Medical Device)

Requirements

• Bachelor's Degree in Regulatory Affairs, Life Sciences (e.g., biology, chemistry) or Engineering.
• 4 - 6 years of experience working in regulatory affairs for medical devices.
• Ability to manage multiple projects and work in a fast paced, changing environment.
• Advance skills in Word and Excel.
• Strong understanding of medical device regulations for pre-market approvals/clearances for medical device.
• Understanding of post-market regulatory requirements of medical device.
• Skill and ability to diagnose, isolate, and resolve complex issues and recommend and implement strategies to resolve problems.
• Requires the ability to present and communicate with various audiences (e.g. senior management and non-technical audiences).
• Position requires up to 15% travel.
• RAC Certification a plus
• Experience working with SAP
• Experience writing 510(k)s and CE technical files.
• Experienced directly managing people including hiring, developing, motivating, and directing people as they work.
• Experience applying knowledge of EPA VOC, Prop 65, FIFRA, OSHA HAZCOM, CPSC, DOT, FDA, and/or VAWD.
• All Successful candidates can expect a very competitive remuneration package and a comprehensive range of benefits.
• Kindly email your resume in a detailed Word/pdf format to ashley@peopleprofilers.com
• We regret that only shortlisted candidates will be notified
• People Profilers Pte Ltd
• Tel: 69509753
• EA Registration Number: R1111375
• EA licence number 02C4944
• EA Personnel: Lee Hui En Ashley

Additional Information

Job Description: Guide regulatory and licensing decision-making processes based on relevant regulatory requirements of medical devices. Complete and maintain regulatory filings by leading internal groups, collaborating with external groups, providing direction to obtain supporting technical information, and implementing focused solutions for identified changes and challenges. Oversee the communication of regulatory requirements to internal or external customers. Lead communication with critical regulators to respond to non-conformances, deficiencies, and questions. Develop and implement processes and procedures to maintain regulatory compliance related to medical device pre- and post-market activities involving regulatory, R&D, quality and medical affairs. Monitor changes in the regulatory and legislative environment. Recommend regulatory pathways, strategies, solutions, and future actions for specific and diverse scenarios, accounting for business objectives and factors relevant to other departments/functional areas. Review and provide direction to ensure supporting evidence meets appropriate regulatory requirements. Assess records against multiple requirements sources, including regulations, guidance documents, and standards utilized in various applicable markets that have been identified as applicable. Oversees professional employees/teams OR typically manages non-professional employees through Supervisors in manufacturing, distribution or office environments.

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