Regulatory Affairs Manager

Regulatory Affairs Manager

CooperVision

Segensworth, United Kingdom

What will you be doing

Responsible for regulatory affairs EMEA function of CooperVision products including product labelling, product maintenance, and product sustainability. Assists with health hazard evaluations, adverse event reporting, product recalls/withdrawals, Clinicaltrials.gov, regulatory project management, and others as assigned and as needed. Supervises RA Specialist.

Consistent with the corporate values, quality policy and procedures, this role is responsible for exhibiting professional behaviour with internal and external business associates that reflects positively on CooperVision, Inc. The individual conveys a trustworthy, credible, and reliable image.

The key deliverables of the role are below:

• Commercial support for Packaging and Labelling reviews
• Management of EU Notified Body relationship and communications for Technical File Documentation for Legal Manufacturer
• Process, issue, and maintenance of Declarations of Conformity
• Product reviews and RAID assessments for Impact of Change to CE certification
• Field Action Regulatory Contact

Essential Functions & Accountabilities

• In collaboration with project team members, defines project requirements and timelines. Organizes, creates, and maintains project plans;
• Communicates project status to cross-functional team and regulatory management;
• Interfaces with project team members to drive regulatory and corporate initiatives to completion;
• Provides regulatory reports (monthly, quarterly, etc.) to regulatory management and other departments;
• Reviews and approves product labelling and marketing material. Initiates new package inserts and other required product labelling;
• Collaborates with Global Packaging/Labelling Operations to ensure that final product meets package labelling requirements for intended destination(s);
• Prepares regulatory submissions and filings, as needed;
• Maintains regulatory files and documents;
• Keeps abreast of regulatory requirements; this includes monitoring EMEA and other agencies regulations and standards;
• Progressive responsibility to assist with health hazard evaluations, adverse event reporting, product recalls/withdrawals, data entry into Clinicaltrials.gov, Regulatory project management, on as needed basis;
• Global Strategies – Author and develop guidance for regulatory positioning/strategies (align with senior management) and communicate to Regional Regulatory/other functional areas;
• Global RA representative on LCM for product improvements especially design changes. Assist the NPI RA group for smooth transitioning of new products into product support;
• Responsible for the coordination of changes that impact marketed product;
• Global rep on projects relevant to product changes, enhancements, and revitalization;
• Develop/improve upon global processes such as Change Management, RA compliance, new product introduction, regional processes and maintain high level of coordination between regional and global RA departments;
• Participate in project initiation discussions with Global Supply Chain and Global Packaging and delegate as required to ensure meeting business goals;
• Global RA representative for labelling; coordinate with global RA representative for Ad/Promo and Global Claims Council;
• Point person for Regional RA to ask questions regarding Operations/Packaging/Labeling/Product related questions. Support audit questions where required.

What skills and experience should you have?

Knowledge, Skills and Abilities:

• Strong leadership attributes. Confidently leads cross-functional discussion and drives projects to completion. Educates others on regulations and company policies and procedures;
• Able to analyze regulations;
• Demonstrated ability to manage and prioritize multiple projects and tasks;
• Effective communicator; able to convey messages in a logical and concise manner;
• Consistently reinforces regulatory expectations and requirements;
• Exceptional attention to detail with strong organizational skills;
• Independent self-starter; manages time effectively and completes tasks on-time with minimal supervision. Flexible and able to self-manage multiple priorities;
• Exceptional technical writing skills;
• Ability to read and understand highly technical material;
• Ability to enter into highly different cultural and regulatory backgrounds worldwide with ‘diplomatic sensitivity’;
• Proficient skills in MS Office applications.

Experience:

• Minimum of 10-15 years of experience in regulated medical device industry;
• Working knowledge of domestic and international regulations, ISO 13485, MDSAP, Medical devices Directive (MDD), Medical Device Regulations (MDR), MHRA, and other regulations that affect medical device compliance;
• Technical writing experience.

Education:

• Bachelor’s Degree in a technical discipline required, e.g. chemistry, engineering, project management. Higher degree a plus;
• Regulatory Affairs Certification highly desirable.

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United Kingdom     Clinical Research     Manager and Executive     Medical Devices     Regulatory Affairs     CooperVision