Regulatory Affairs Associate II

JOB TITLE

Regulatory Affairs Associate II

DEPARTMENT

Regulatory Affairs

JOB CODES

Exempt

MAIN PURPOSE OF JOB AND OBJECTIVES

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Support for the regulatory side of the business to ensure compliance with corporate procedures and timely product approvals with domestic and international regulatory requirements.

POSITION IN ORGANISATION

Position in organisation can be found on the Organisational Chart via the company intranet.

KEY DUTIES

• Assist in the preparation of US, EU, and rest of world regulatory submissions as required.
• Review proposed labelling, packaging, advertising, and promotional materials after evaluating conformance to regulations.
• Review, edit and provide regulatory approval for project documentation.
• Review and analyse technical protocols, data, and reports generated by other departments.
• Partner with cross functional teams by providing preliminary regulatory guidance and support to product development teams for strategic planning, design and development, and compliance activities.
• Evaluate how design and manufacturing changes affect product registrations.
• Evaluate compliance to recognized and harmonized standards.
• Assist in SOP development, review, and initiation.
•  Stay abreast of regulatory procedures and changes in regulatory climate.
• Respond to requests from regulatory agencies and/or distributors to prepare and submit documentation for marketing approvals in other countries.
• Provide Regulatory Affairs support during internal and external audits.
• Prepare the necessary documents to obtain Certificates of Exportability and Certificates to Foreign Government from US FDA
• Prepare and submit medical device reports or vigilance reports.
• Perform various other duties as assigned.

DIMENSIONS & LIMITS OF AUTHORITY

COMPANY

REQUIREMENTS

1. Must work within requirements of company handbook and policy statements.

Note: Company Handbook, Policy Statement and Authorisation of Limits do not form part of the quality system

QUALITY

REQUIREMENTS

1. Maintain awareness of the relevance and importance of activities performed and how they contribute to the achievement of quality objectives.
2. Work within the QMS always, ensure accurate completion of records and highlight issues to immediate supervisor any issues affecting quality.
3. Responsible to ensure facility, processes and documentation always remain in a state of audit readiness.

EH&S REQUIREMENTS

1. Take care of your own health and safety and that of others who may  

be affected by your actions.

2. Work co-operatively to highlight issues affecting Environmental Health and Safety

QUALIFICATIONS & EXPERIENCE

• Excellent interpersonal skills to interface with project team members and able to contribute to the overall success of the team.
• Excellent written, verbal communication and presentation skills are required. 
• Excellent attention to detail and ability to coordinate multiple activities simultaneously.
• Excellent computer skills including expertise in Microsoft Office Products
• Excellent organizational skills to maintain communications with teams and regulatory agencies.
• Bachelor’s degree in science or engineering (or related field) from an accredited college or university and 3 years direct experience in medical device regulatory affairs
• Minimum 5 years direct experience in medical device regulatory affairs if no degree.
• Knowledge of US and European regulatory processes, including Class III is strongly preferred.
• Preferred experience in a medical device regulatory environment, preparing submissions (IDEs/IDE supplements, PMAs/PMA Supplements, 510(k)s and Design Dossiers/Technical files) for Class II and III medical devices and a successful track record is required.
• Knowledge of Design Control processes and controls (21 CFR 820)
• Knowledge of Regulatory Standards needed in the medical device environment (ISO 13485, current revision)
• Awareness of Medical Device Directive and Medical Device Regulation.