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Regulatory Affairs Specialist Indiana
SUMMARY
This is an experienced level position in Regulatory Affairs (RA). This position
requires an intermediate understanding company's products and their use as well as an understanding of the regulatory
admissions process. Works under minimum supervision.
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 RA policy and procedures
- May provide training and/or guidance to new entry-level associates
COMPETENCIES
- Demonstrated strong writing
and communication skills
- Strong
attention to detail, ability to multi-task
- Knowledge
of overall business environment, the orthopaedic 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
REQUIREMENTS
Education/Experience
- 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
- A combination of education and experience may be considered
Travel:
Up to 15%
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