Sr Lifecycle Regulatory Specialist
Company: Exactech, Inc.
Posted on: June 12, 2021
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):
Communicate directly with regulatory agencies and health
authorities regarding registrations, submissions and regulatory
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.
Identify and communicate regulatory impact, regulatory
requirements and submission deliverables, and execute to achieve
Provide input to the change teams on project and test plans,
ensuring that the plans address all elements of the global
Maintain awareness of the global regulatory environment; assess
and communicate the impact of key environmental changes LC RA
initiatives and strategies environment.
Review and approve post-launch advertising and promotion
Oversee compliance with any regulatory Conditions of
Support regulatory audits and inspections
Interpret and apply medical device regulations and standards
Know and apply the Quality System and any appropriate Federal
and International standards.
- Assist and support other employees, teams, and sales personnel
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
- Regulatory Affairs Certification (RAC) preferred
Functional/Technical Knowledge, Skills and Abilities Required:
Proficiency with windows-based office productivity tools (Microsoft
Keywords: Exactech, Inc., Gainesville , Sr Lifecycle Regulatory Specialist, Other , Gainesville, Florida
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