Regulatory Affairs Specialist Job

REGULATORY AFFAIRS SPECIALIST is needed for a CONTRACT position with Yoh's client located in WARSAW, IN.

WHAT YOU WILL BE DOING:

- This is an experienced level position in Regulatory Affairs (RA). This position requires an intermediate understanding of company products and their use as well as an understanding of the regulatory admissions process. Works under minimum supervision.
- 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
- May provide training and/or guidance to new entry-level associates

WHAT YOU NEED TO BRING TO THE TABLE:

- US Bachelor's Degree in life sciences, technical (engineering) or related field (or non-US equivalent).
- Advanced degree preferred
- Four to six (4-6) 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
- A combination of education and experience may be considered
- Knowledge of overall business environment, the orthopedic industry and the marketplace
- Mastery of relevant regulations pertinent to medical devices, biologics, drugs and combination products
- Able to identify risk in Regulatory strategies
- Knowledge of FDA regulations (including labeling regulations) and regulations outside the US preferred

IF THIS SOUNDS LIKE YOU, APPLY NOW!

RECRUITER: James Dangler

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

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