Regulatory Affairs Lead

Job Description Summary

Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and postmarket compliance, working closely with healthcare regulatory bodies globally. In-depth understanding of key business drivers; uses this understanding to accomplish own work. In-depth understanding of how work of own team integrates with other teams and contributes to the area.

Job Description

Job Profile Summary

Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and postmarket compliance, working closely with healthcare regulatory bodies globally. In-depth understanding of key business drivers; uses this understanding to accomplish own work. In-depth understanding of how work of own team integrates with other teams and contributes to the area.

Roles and Responsibilities

• Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and post market compliance, working closely with healthcare regulatory bodies globally
• Developing in-depth knowledge of a discipline. Uses prior experience and acquired expertise to execute functional policy/strategy.
• A job at this level is likely to be an individual contributor, with proven interpersonal skills. Communication with direct colleagues and the business about design and coordination services rendered. Provides informal guidance to new team members. Explains complex information to others in straightforward situations.
• Impacts projects, processes and procedures in own field. The role operates with some autonomy, but is focused on execution of activities/provision of advice within an enabling discipline covered by standard functional practices and procedures. Activities require professional judgment, but may require more senior levels of guidance.
• Utilizes technical expertise and judgement to solve problems. Leverages technical skills and analytic thinking required to solve problems. May use multiple internal sources outside of own team to arrive at decisions.

Required Qualifications

• Pharmacist degree or Master’s degree in a scientific discipline from an accredited university or college.
• Significant experience in Regulatory Affairs within medical device industry, including regional or global roles.
• Advanced knowledge of applicable regional and international regulatory frameworks and postmarket requirements.

Desired Characteristics

• Strong oral and written communication skills. Demonstrated ability to analyze and resolve problems. Ability to document, plan, market, and execute programs. Established project management skills.
• Demonstrated experience interfacing with regulatory agencies (e.g. EDA, NMPB, MoH in Libya, etc.) and standards bodies such as IEC, ISO, and relevant regional bodies.
• Experience with postmarket surveillance activities, including adverse event reporting, vigilance systems, recalls, and field safety corrective actions.
• Strong leadership, stakeholder management, and project management skills, with the ability to prioritize and execute in a dynamic, matrixed environment.
• Demonstrated experience working in a cross-functional environment and proven ability to influence and build consensus among multiple internal functions, external stakeholders (trade association, regulators).

Additional Information