United Spinal Association Jobs

CooperVision, a division of CooperCompanies (NASDAQ: COO), is one of the worlds leading manufacturers of soft contact lenses. The Company produces a full array of daily disposable, two-week and monthly contact lenses, all featuring advanced materials and optics. CooperVision has a strong heritage of solving the toughest vision challenges such as astigmatism, presbyopia and childhood myopia; and offers the most complete collection of spherical, toric and multifocal products available. Through a combination of innovative products and focused practitioner support, the company brings a refreshing perspective to the marketplace, creating real advantages for customers and wearers. For more information, visitwww.coopervision.com.

Job Summary:

The Senior RA Specialist Regulatory Intelligence (RI) will provide global regulatory intelligence expertise, regulatory affairs, pre-clinical, clinical, and commercial areas for investigational and marketed products. The candidate will ensure that regulatory/competitive intelligence, or scientific/regulatory information searching, summarization, assessment and dissemination are provided to the business. The candidate will proactively monitor emerging external scientific and regulatory trends, approvals, and strategies to inform and influence the development of regulatory strategies and policies both across and within portfolio areas. The candidate will work with Global and Regional Regulatory Affairs to provide both routine and ad hoc requested information including implementing a commenting process on health authority guidance and directives.

Essential Functions & Accountabilities:

• Provide impactful summaries and strategic advice, back to the business, regarding assigned internal/external activities. Provide leadership to influence the regulatory environment to meet business needs.
• Develop and execute a regulatory intelligence strategy. Keep abreast of internal and external changes, trends, developments and other dynamics relevant to the regulatory environment that may have impact to the regulatory and access strategies and propose action plan.
• Understand and interpret complex scientific issues across projects and area(s) of responsibility as it relates to regulatory requirements, regulatory intelligence, policy and strategy for the region. Experience working with a major regulatory agency, specific experience in government affairs or policy is desired.
• Follow regulatory plans and interface with project team members, both within the organization and with a range of external groups, to drive corporate regulatory initiatives to completion.
• Liaise with internal functions such as quality assurance (QA) Operations, Operations, Manufacturing, Professional Services, Legal, RA, and Marketing to provide necessary information and documentation requested.
• Collect regional regulatory intelligence and provide monthly reports. Monitor impact of changing regulations on submission strategies and notify appropriate departmental personnel.
• Maintain regulatory files and documents in addition to internal regulatory tracking documents. This includes maintaining communication with supervisor and other departments to provide status reports.
• Assess applicability of documents of external origin (DOEOs) (i.e., standards, regulations, guidance) and maintain procedures associated with this process, including regulatory intelligence (RI).
• Respond to corporate inquiries and follow up to internal processes (i.e., Regulatory Affairs Impact Documents (RAIDs), RA database, RI).
• Lead the development and refinement of RI processes and procedures to build efficiencies, track minutes from related meetings, and coordinate RI review meetings.
• Develop and maintain RI process and other regulatory/quality systems processes as needed.
• Generate a meaningful output of RI by translating learnings to educate the business about RI and how it impacts the business. Ability to prepare and publish regulatory intelligence newsletter and presentations. Take the lead in delivering the regulatory newsletter content to the organization, as well as ownership of the content and updates to RI globally.
• Prepare new/revised regulatory requirements for CooperVision site Management Reviews.
• Prepare MDSAP Chapter 2 data to CooperVision MDSAP sites in preparation for their audits.
• Apply an understanding of the underlying science as it relates to RI, for contact lens and contact lens care products.
• Maintain consistent oversight of deliverables. Keep management and all internal customers, partners and stakeholders abreast of progress and provide interim updates on ongoing activities and current initiatives. Ensure issues are escalated when needed and encourage resolution at the appropriate level.
• Lead routine and ad hoc meetings within function and cross-functionally.Present to senior management as relevant.
• Model the corporate values.
• Travel is 5%.

CooperVisions 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 andregulatory requirements.

Qualifications

Knowledge, Skills and Abilities:

• Actively develop an understanding of health authority inner workings, regulatory requirements, and potential interpretation of regulatory guidelines. Knowledge of regulations and guidance governing medical device in all phases of development, including post-marketing, in the US and/or EU, with a good understanding of basic regulatory requirements in emerging markets.
• Excellent collaboration/relationship building, strong influencing and negotiation skills, integrity and adaptability. Outstanding written and oral communication skills as well as managing and adhering to timelines.
• Must be strong overall and able to train/develop staff in the area of regulatory intelligence such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory trends.
• Understand and interpret complex scientific issues across projects as it relates to regulatory requirements, regulatory intelligence, and strategy for the region.
• Have familiarity with the database-oriented software and/or the Agile PLM (product lifecycle management)/global RA database reporting functions.
• Project management, technical writing, and analytical skills
• Conduct self in a professional manner with coworkers, management, customers, and others.
• Working knowledge of US regulations and guidance including but not limited to FDA 21 CFR, MDSAP, ISO 13485, UKCA, MedDO, MDD, and MDR.
• Strategic and critical thinking, communication, leadership, attention to detail, self-motivation
• Ability to read and understand highly technical material

Work Environment:

• Prolonged sitting in front of a computer
• Works scheduled hours and is ready to work at scheduled start times

Experience:

• 1-5 years of regulatory intelligence experience required.
• Sound knowledge of intelligence tools and methods.

Education:

• BS Advanced scientific-related degree preferred; BA accepted based on experience. Advanced degree preferred

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 $81, 372 and $108, 496 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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Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity

Minimum Salary: 0.00 Maximum Salary: 0.00 Salary Unit: Yearly