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Sr Lifecycle Regulatory Specialist

Company: Exactech, Inc.
Location: Gainesville
Posted on: June 12, 2021

Job Description:

Purpose:

The Senior Lifecycle Regulatory Specialist provides regulatory support of the Lifecycle (Postmarket) projects of commercialized products. Accountabilities include activities such as assessment of proposed changes for regulatory impact, regulatory strategy and support for change projects, compliance with Conditions of Approval, EU renewals and regulatory review & approval of advertising and promotion. The Lifecycle Regulatory Specialist will partner with the cross functional team members (e.g., BUs, Operations, etc.) and regulatory colleagues (e.g., the BU, Regional and RO & RCoE RA teams) to develop and execute global regulatory strategies in support of commercialized products.

Duties and Responsibilities (Key Deliverables):

  1. Communicate directly with regulatory agencies and health authorities regarding registrations, submissions and regulatory strategies.

  2. In partnership with the business and regulatory colleagues (e.g., BU, Operations, and the BU, Regional and RO & RCoE RA teams) develop and execute regulatory strategies and timelines to support proposed changes to commercialized product.

  3. Identify and communicate regulatory impact, regulatory requirements and submission deliverables, and execute to achieve regulatory milestones.

  4. Provide input to the change teams on project and test plans, ensuring that the plans address all elements of the global regulatory strategy.

  5. Maintain awareness of the global regulatory environment; assess and communicate the impact of key environmental changes LC RA initiatives and strategies environment.

  6. Review and approve post-launch advertising and promotion (A&P)

  7. Oversee compliance with any regulatory Conditions of Approval.

  8. Support regulatory audits and inspections

  9. Interpret and apply medical device regulations and standards

  10. Know and apply the Quality System and any appropriate Federal and International standards.

  11. Assist and support other employees, teams, and sales personnel as necessary.

Job Requirements:

Education: Bachelor's Degree in a related field from an accredited institution required; Master's Degree preferred

Experience: Minimum of 5 years' experience in the medical device industry specifically in Regulatory Affairs.

  • Bachelor's Degree in physical or life sciences preferred.
  • Orthopaedic device industry experience preferred.
  • Experience in US, EU and/or international submissions/registrations required Working knowledge of US, EU and international medical device regulations required
  • Demonstrated experience leading in-depth technical and strategic discussions with Health Authorities required
  • Demonstrated ability to influence and negotiate with cross-functional partners and stakeholders, both internal and external required
  • Regulatory Affairs Certification (RAC) preferred

Functional/Technical Knowledge, Skills and Abilities Required: Proficiency with windows-based office productivity tools (Microsoft Office)

Keywords: Exactech, Inc., Gainesville , Sr Lifecycle Regulatory Specialist, Other , Gainesville, Florida

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