Regulatory Affairs Specialist

Job Description

Job Description

The Regulatory Affairs Specialist oversees all regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. This role involves developing processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. The specialist establishes monitoring policies and procedures to ensure compliance with existing regulations and anticipates new or changing regulations. They coordinate with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, the specialist investigates and addresses any reported issues of non-compliance.

Duties and responsibilities:

· Create and implement regulatory strategies to ensure adherence to regulations.

· Preparation and submission of necessary regulatory documentation, such as licenses, certifications, 510(k) clearances, technical files, and permits.

· Establish policies and procedures for continuous compliance monitoring.

· Address new regulations by collaborating with internal stakeholders on strategies.

· Investigate and resolve non-compliance issues.

· Offer regulatory guidance to departments like product development, manufacturing, and quality assurance.

· Oversees interactions with external regulatory consultants.

· Act as the organization's representative in dealings with regulatory agencies and industry groups.

· Functions as the Management Representative, ensuring the quality management system processes are established, implemented, and maintained.

Required Qualifications:

· Bachelor's degree in a related field (e.g., life sciences, engineering, regulatory affairs).

· Minimum of 5-7 years of experience in regulatory affairs within the medical device, pharmaceutical, or biotechnology industries.

· Strong knowledge of regulatory requirements and guidelines (e.g., FDA, EU MDR).

· Excellent written and verbal communication skills.

· Strong organizational and project management skills.

· Ability to work effectively in a team environment and manage multiple projects simultaneously.

Preferred Qualifications:

· Advanced degree (e.g., Master's, PhD) in a related field.

· Regulatory Affairs Certification (RAC).

· Experience with international regulatory submissions and approvals.

Physical / Mental Demands:

· Working conditions are normal for an office environment.

· Work may require weekend and evening work.

· Work under stress in a fast-paced environment.

· Must be alert, able to concentrate, and use good judgment.

· Must be able to work under conditions that require sitting, standing, walking.