Regional QARA Manager (Medical Device)

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.

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 [Confidential Information]

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