Regulatory affairs consultant

Part-time Regulatory Affairs Consultant (3 days per week) Responsibilities.

The Senior Manager, Global Regulatory Affairs is responsible for creating and implementing regulatory strategies for products that require government approval including: Develop and execute global strategies for new, or for maintaining existing product registrations.

Prepare, submit and maintain all global registrations; write and/or submit 510(k)s, IDEs, PMAs, Technical Documentation, Post Market Reports, etc.

Ensure compliance with global regulations and regulatory agencies.

Interpret the intent of regulations and policies and provide such information to management.

Evaluate global directives including ISO standards, assess the impact to the AcuFocus business and develop regulatory solutions.

Interface with the US FDA as well as other applicable international regulatory authorities.

Coordinate with international contacts (ex.

distributors) on product changes and regulatory notification/approval requirements.

Support Quality, Engineering, Clinical, Medical Affairs and Marketing to ensure applicable domestic and international regulations related to risk management and medical device reporting are met.

Maintain proficiency in global regulatory requirements.

Provide continuing regulatory education and dissemination of regulatory information to the product development, marketing, and clinical affairs organizations.

Review and approve labeling, advertising and claims.

Review and approve protocols and reports (ex.

design verification, design validation, process qualifications, biocompatibility studies, shelf life studies, animal studies, clinical studies, etc.).

Requirements.

The Senior Manager, Global Regulatory Affairs shall possess a Bachelor’s degree in a scientific discipline or related field and have at least 6-8 years of experience in all aspects of Global Regulatory Affairs in the Medical Device Industry.

Demonstrated record of expertise preparing global regulatory submissions for medical devices, as well as maintaining global product registrations (Class III US /IIb Europe).

Comprehensive understanding of US and international medical device regulations / standards and quality principles.

Effective communicator; ability to interface with all levels of management and regulatory agency representatives.

Proactive; presents timely, strategic global regulatory guidance.

Skilled in technical writing.

High level of attention to detail.

We offer competitive compensation (based on experience).