Reg Affairs Associate

Welcome to ZimVie, a new, publicly traded global company focused on improving quality of life for our patients.
Our company is founded on a legacy of established brands, medical experts and over $1B in annual revenue.
We design, manufacture, and distribute a comprehensive portfolio of innovative solutions for implant dentistry, spinal surgery and bone growth stimulation.
Our seasoned leadership and dedicated global team of more than 2,500 is focused on shaping an exciting future for ZimVie — we hope you'll consider being a part of it
**Job Summary**:
Responsible for assisting the team with regulatory filings as necessary to market Zimmer Biomet products.
This is an entry level position, providing training towards full competency in Regulatory Affairs (RA).
This position requires a basic understanding of medical devices and their use as well as a basic understanding of the regulatory submissions process.
May perform some or all of the following functions, depending on specific assigned focus.
**Principal Duties and Responsibilities**:

- Coordinate and assist in the preparation of technical documentation for use in regulatory submissions worldwide but with a primary focus on Latin America
- Assist with the research, analysis and communication of information pertaining to the appropriate regulatory pathway for new or modified products
- May aid in regulatory direction to development project teams as a core team member; supports regulatory strategy for new products
- Reviews proposed labeling for compliance with applicable international and country regulations
- Support development of package inserts
- Reviews and evaluates promotion and advertising material for compliance with applicable international regulations
- Supports and reviews proposed product changes for impact on regulatory status of the product
- Follows Zimmer Biomet RA policies and procedures
- Miscellaneous responsibilities as assigned
- This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions" for purposes of the ADA._

**Expected Areas of Competence (i.e., knowledge, skills, and abilities)**
- Ability to communicate (writing/speaking) in Spanish and English
- Strong writing, communication, and interpersonal skills
- Strong attention to detail
- Strong problem-solving and analytical skills
- Ability to work with rapid changes; flexible and able to balance competing priorities
- Self-motivated and capable to work in a diverse, fast-paced and dynamic environment
- Ability to build strong relationships; communicate effectively at all levels
- 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
- Limited regulatory submission preparation experience a plus
- Familiarity with Latin American regulatory pathways a plus
- Familiarity with US and Canadian regulations a plus
- Experience in a regulated industry a plus

**Travel Requirements**

***Up to 20%

Req #1393

ZimVie is an Equal Opportunity Employer committed to diversity and inclusion in the workplace.
All qualified applicants for employment and employment decisions, including hiring, promotion, transfer, demotion, evaluation, compensation, and separation, are considered without regard to race, color, national origin, ancestry, sex, sexual orientation, gender, gender identity, gender expression, transgender status, religion, religious beliefs, age, marital status, physical or mental disability, pregnancy status (including childbirth, lactation, breastfeeding or related medical conditions), parental status, genetic characteristics or information (including family medical history), political affiliation, military or veteran status or other classifications protected by applicable federal, state and local laws.
ZimVie generally does not sponsor applicant work visas for this position.
Requisition ID: 1393