Associate II, Regulatory Affairs Strategy

Summary of the Position:

Regulatory Affairs Associate is responsible for providing support in ensuring compliance with EU, US, and global medical device regulatory requirements. This position is primarily focused on supporting international registration requirements triggered by the EU Medical Device Regulation (Regulation (EU) 2017/745, as amended). The role will also be responsible for supporting other regulatory affairs activities related to life cycle management of on-market medical devices registered globally to meet corporate submission and registration objectives for timely approval.

Major Accountabilities

• Working with Alcon global partners and support worldwide registrations efforts.
• Works in close collaboration with internal customers and supports multiple projects to align on regulatory strategy to achieve business objectives.
• Manages requests from Alcon international country affiliates for registration activities associated with the EU MDR. Provides responses and requested documentation in support of those registration requirements.
• Support communications with US and international affiliates and regulatory personnel.
• Ensures compliance with global regulatory requirements and adherence to internal policies and processes.
• Provides high quality regulatory support for assigned products/projects.
• Develops documents that are clear, concise, and complete to facilitate and maintain registration renewal, tenders, and licenses.
• May support regulatory affairs team members to prepare, consolidate, and follow-up on change assessments for global regulatory strategies.

Key Performance Indicators

• Demonstrated ability to coordinate and work effectively with multiple stakeholders
• Ensures timely, clear communications to internal stakeholders on project status and issues
• Serves as role model and embraces corporate Values and Behaviors
• Demonstrated good organizational and time management skills, including the ability to work on multiple projects and adhere to timelines
• Meets individual goals as defined in the annual objectives
• Ability to support the business by communicating effectively, managing issues proactively, resolving conflicts and mitigating risks
• Ability to work in a matrixed environment and influence internal partners to achieve desired business outcomes

Ideal Background (State the minimum and desirable education and experience level)

Education

Bachelor’s Degree or Equivalent years of directly related experience (or high school +10 years; Assoc.+6 years; M.S.+0 years)

Experience requirement:                                    

2-5 Years of Relevant Experience in medical device regulations and/or regulatory affairs for medical devices.

Languages:

The ability to fluently read, write, understand, and communicate in English.

Timings

Willing to work US PST/CST time zones

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