REG0104-Regulatory Affairs Sr Specialist Job in Warsaw 46580, Indiana Us
Company
Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer designs, develops, manufactures and markets orthopedic reconstructive, spinal and trauma devices, dental implants, and related surgical products. Zimmer has operations in more than 25 countries around the world and sells products in more than 100 countries. Zimmer’s 2010 sales were approximately $4.2 billion. The Company is supported by the efforts of approximately 8,000 employees worldwide.
Zimmer was founded in 1927 as a trauma company, and remains a major player in this nearly $5 billion global market. The Zimmer Trauma Division offers a comprehensive line of trauma product devices used to stabilize damaged or broken bones and their surrounding tissues to support the body’s natural healing process. These include internal fixation devices such as plates, screws, nails, and wires and pins, as well as external fixation devices that stabilize fractures while applied externally to the limb. The Trauma Division is focused on addressing unmet clinical needs and continues to work on aligning Minimally Invasive Solutions technologies with Trauma products, as well as integrating Ortho biologics and other next generation technologies into the portfolio of Zimmer trauma solutions. The Zimmer Trauma Division is located in Warsaw, Indiana.
Job Summary
This is an experienced level position in Regulatory Affairs (RA). This position requires an intermediate
understanding of Zimmer products and their use as well as an understanding of the regulatory admissions process. Works under minimum supervision.
Principal Duties Responsibilities
Coordinates the FDA regulatory submission process; may aid in authoring and/or publishing electronic
Submissions.
Leader in the development of dossiers for registration of products in countries outside the US; including authoring and/or publishing electronic submissions.
Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for new products.
Evaluate risk of proposed regulatory strategies; may offer solutions.
Reviews proposed labeling for compliance with applicable US and international regulations.
Manages the process of writing package inserts.
Reviews and evaluates promotion and advertising material for compliance with applicable regulations.
Reviews proposed product changes for impact on regulatory status of the product.
Interprets and applies FDA regulations to business practices and provides regulatory input, advice, and guidance to the organization.
Establishes Zimmer RA policy and procedures.
May provide training and/or guidance to new entry-level associates.
Expected Areas of Competence (KSA's)
-Demonstrated strong writing and communication skills.
-Strong attention to detail, ability to multi-task.
-Knowledge of overall business environment, the orthopedic industry and the marketplace.
-Mastery of relevant regulations pertinent to medical devices, biologics, drugs and combination products.
-Ability to function well as a member of the team and build relationships between RA and other areas of the organization.
-Able to identify risk in Regulatory strategies.
-Able to train entry level RA associates.
-Knowledge of FDA regulations (including labeling regulations) and regulations outside the US preferred.
-Basic computer skills, including Microsoft Office Suite.
Education/Experience Requirements
-US Bachelor’s Degree in life sciences, technical (engineering) or related field (or non-US equivalent).
-Advanced degree preferred
-Four to Six years’ experience in Regulatory Affairs
-Advanced experience in the areas that may include preparation of dossiers for product registrations outside the US; preparation of submissions to the FDA strongly preferred
-Regulatory Affairs Certification (US or EU) preferred
Travel Requirements
-Up to 15%
Interested candidates should apply online at: https://jobs.zimmer.com/sap/bc/webdynpro/sap/zhrrcf_a_unreg_ext_job_srch_us?sap-language=EN