Regulatory Affairs Specialist

hace 7 días

Bogota, Colombia Zimmer Biomet A tiempo completo

**Requisition Number**: AMER27699

**Employment Type**: Full-time

**Location**: Bogota

**Job Summary**: Responsible for assisting the team with regulatory change assessments and filings as necessary to market and maintain Zimmer Biomet products. This position requires an intermediate understanding of medical devices and their use as well as a understanding of the regulatory pathways (US and EU) for change assessment through approval.

**Principal Duties and Responsibilities**: - Provide regulatory assessment of product changes (including but not limited to material, manufacturing, cleaning, sterilization, and packaging changes), utilizing both local procedure and established regulatory guidance and standards
- Assist with assembly, distribution, storage, tracking and retrieval of information pertinent to the regulatory process, including the regulatory submissions process. May author and publish electronic submissions
- Respond to requests from foreign government and/or distributors as needed
- Assist with the research, analysis and communication of information pertaining to the appropriate regulatory pathway for approval of product changes
- Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for significant product changes
- Evaluate risk of proposed regulatory strategies; may offer solutions
- Reviews proposed labeling for compliance with applicable global regulations
- Updates package inserts and labeling to support product changes as appropriate
- Communicates with regulatory and governmental agencies with supervision
- Applies FDA regulations to business practices and provides regulatory input, advice and guidance to design teams

**Expected Areas of Competence**: - Strong writing, communication, and interpersonal skills
- Strong attention to detail; ability to multi-task and balance competing priorities
- Knowledge of overall business environment, the orthopaedic industry, and the marketplace
- Ability to learn and stay abreast of regulations pertinent to medical devices, biologics, drugs and combination products as needed, based on functional area
- Ability to build relationships between Regulatory Affairs and other areas of the organization; ability to communicate effectively at all levels and cross-functionally
- Knowledge of FDA, EU, and other regulatory body regulations
- Ability to identify risk in Regulatory strategies
- Strong problem solving skills Basic computer skills, including Microsoft Office Suite

**Education/Experience Requirements**: - Bachelor’s degree (or non-US equivalent) required; concentration in life sciences, technical/engineering or related field, preferred
- A minimum of one year of experience in orthopaedic or medical device industry preferred
- A minimum of 3 years of experience in Regulatory Affairs, Engineering, Quality, or related field required
- Regulatory Affairs Certification (US or EU) preferred
- A combination of education and experience may be considered
- CPI Core Production Introduction
- Change Review
- Ad/Promo
- Labeling Updates RA Catch-up projects MDR transition Submission of regulatory files International Registration Requests

**Travel Requirements**: 15%

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