Senior RA Manager

As a Senior Regulatory Affairs Manager at CooperVision, this role will ensure compliance with regulatory requirements for our medical device portfolio.  The Sr. RA Manager will lead regulatory strategy development and execution to support product development, registration, and commercialization efforts.  Reporting to the Director of Regulatory Affairs, the candidate will collaborate cross-functionally with internal teams and external stakeholders to drive regulatory initiatives and maintain regulatory compliance throughout the product lifecycle.

 

• Develop and execute regulatory strategies for new product development, including premarket submissions, regulatory assessments, and compliance activities.
• Provide regulatory guidance and support to project teams, ensuring alignment with regulatory requirements and standards (Americas).
• Prepare and submit regulatory submissions, including 510(k) premarket notifications, PMA applications, IDEs, and other regulatory filings as required.
• Participate in the preparation for meetings with regional regulatory agencies.
• Collaborate with cross-functional teams to ensure regulatory requirements are integrated into product development plans.
• Provide regulatory support for post-market activities, including field corrections, labeling updates, and advertising and promotional review.
• Participate in regulatory meetings, conferences, and industry forums to stay abreast of emerging trends and best practices in regulatory affairs.

 

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.

 

Knowledge, Skills and Abilities:

• Demonstrates excellent verbal and written communications skills; can provide direction to a team and to influence peers and team members appropriately.
• Demonstrates excellent technical or analytical knowledge base, with the ability to assess data, processes and understand the regulatory or process implications.
• Able to gather information or assign tasks or activities for one or more projects to manage competing priority jobs, and delegates special projects to junior staff if applicable as needed.
• Demonstrates excellent attention to detail, teamwork, and initiative; maintains confidentiality; maintains meticulous attention to project deadlines.
• Actively participates in RA and cross functional meetings and shares information on projects and challenges openly.
• 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.

 

Experience:

• 8+ years of experience in an FDA regulated industry required; preferably within the medical device industry, with a focus on Class II and Class III devices.
• Ability to develop innovative strategies and creative solutions within the regulatory context within the scope of regional requirements and available resources.
• Ability to comply with constantly changing regulatory procedures and prioritize work effectively.
• Ability to analyze and resolve non-routine regulatory issues using independent judgement.
• Strong working knowledge of US regulations and guidance including but not limited to FDA 21 CFR 820, MDSAP, and ISO 13485.
• Strong initiation and organizational skills.
• Previous experience working in a geographically diverse business environment.

 

Education:

• Bachelor’s Degree from a four-year college or university.
• Strong 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 $134,101 and $191,573 per year 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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