- Provide regulatory support through the product life cycle on product
project teams (e.g., developing regulatory strategies, timeline
development, change control and preparing submission related documents)
- Prepare 510(k)s, IDEs, PMA and/or international submissions as
required
- Assist in technical interface with international reviewers and
respond to questions
- Provide the appropriate information to support international product
registrations
- Provide timely review of product labeling and marketing claim for
regulatory compliance; approve as directed
- Provide support required for CE marking activities, including
preparation and maintenance of product technical files
- May provide direction of other personnel to accomplish duties
| Basic Qualifications
- Knowledgeable of the U.S. or European medical device regulations
- Excellent written and verbal communication skills
- Self-motivated and able to work independently, having the ability to
take ownership of her/his responsibilities
- Able to prioritize and handle several projects concurrently
- Technical writing skills and be proficient at compiling successful
submissions for the appropriate audience
- Able to provide leadership and mentoring skills to less experienced
regulatory personnel
- Able to maintain confidentiality in dealing with regulatory and
clinical documentation
Language Skills: Must have command of the English language.
Mathematical Skills: Should have mathematical skills commensurate with
educational background and necessary for describing and summarizing laboratory
and/or clinical data in product registration submissions.
Reasoning Ability: Must demonstrate the ability to plan and complete
regulatory pathway determinations, product registration submissions and other
documentation. Education and/or Experience
- BS in a scientific discipline with over 5 years employment in the
areas of project registration, compliance or quality systems; or
- Combination of education and experience determined to be equivalent
Physical Demands
- Must be able to operate computer and office equipment as needed
- Must be able to travel via airlines as needed
Work Environment
Traditional office environment |
