Regulatory Affairs Specialist at CooperVision, Inc in Los Angeles, California

Job Description:

Scope: 

As an individual contributor, the Regulatory Affairs (RA) Specialist acts as a link between the company and regulatory authorities, ensuring that products are distributed in compliance with local regulations. The individual will identify data needed, obtain data, and ensure they are effectively presented for the registration of products in North America.  

Job Summary:

The Regulatory Affairs Specialist will be responsible for combining scientific, regulatory, and business issues to enable projects that are developed, manufactured, and distributed to meet local regulations and requirements. 

Essential Functions & Accountabilities:

• Evaluates manufacturing changes for impact on North America regulatory affairs approvals, clearances, registrations, and licenses. 


• Determine and communicate submission and approval requirements.


• Prepares FDA submissions for regulatory approvals.


• Assist in the review of advertising and promotional items.


• Must assure that all deadlines are met and provide effective leadership without direct authority. 


• Keeps abreast of regulatory requirements, this includes monitoring FDA and standards.


• Maintains communication with supervisor and other departments to provide regulatory status reports.


• Participates in developing less experienced staff by setting an example, providing guidance, and offering counsel.


• Organize and track complex information.


• Reviews and approves device labeling for compliance with applicable regulations.


• Responds to corporate inquiries and follow up to internal processes.

CooperVision’s management team is committed to the development of and implementation of the quality management system and maintaining its effectiveness by communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements.

Qualifications

Knowledge, Skills and Abilities:

• Excellent oral and written communication skills, with ability to communicate with diverse populations. Able to convey messages in a logical and concise manner.


• Must be proficient with Microsoft Office including the ability to develop MS PowerPoint presentations and Excel spreadsheets (including data manipulations and graphing).


• Ability to read and understand highly technical material.


• Ability to meet deadlines.


• Strong problem-solving competency.


• Works scheduled hours and is ready to work at scheduled start times. Adapts readily to changes in workload, staffing, and scheduling.


• Complies with all company policies and procedures.


• Complies with management direction. Seeks assistance from supervisor in identifying and reporting problems or concerns relating to job functions.


• Conducts self in a professional manner with coworkers, management, customers, and others.


• Models the corporate values.

Work Environment:

• Remote.


• Willing to work in a fast-paced environment.

Experience:

• 1-3 years of experience in an FDA regulated industry required, preferably with medical devices.


• Experience evaluating manufacturing changes for impact on North America submissions.


• Working knowledge of US regulations and guidance including, but not limited to, FDA 21 CFR 820, MDSAP, and ISO 13485.


• Strong working knowledge and experience with US FDA.


• Previous experience working in a geographically diverse business environment.

Education:

• Bachelor’s Degree from a four-year college or university.


• Working knowledge of medical device regulations, with formal education in regulatory discipline preferred.


• RAPS Certification (RAC) experience is a plus.

Affirmative Action/Equal Opportunity Employer. Minority/Female/Disability/Veteran

For U.S. locations that require disclosure of compensation, the starting base pay for this role is between $76,163 and $101,551 and may include cost of living adjustments.  The actual base pay includes many factors and is subject to change and modification in the future.  This position may also be eligible for other types of compensation and benefits.

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