Regulatory Affairs Specialist II
Covington, GA Posted: 9/17/2020
A Global Medical Device company has an opening for a Regulatory Affairs Specialist II.
The Regulatory Affairs Specialist II is responsible for implementation of regulatory strategies including domestic and international submissions and other support of product project team.
ESSENTIAL DUTIES AND RESPONSIBILITIES including the following. Other duties may be assigned.
- Develop strategies as needed for Sustaining Engineering changes and / or New Product Development
- Review Change Requests / Sustaining Engineering changes and provide RA strategy for US and EU assessments as well as coordinate international responses.
- 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)
- May prepare and audit 510(k)s and/or international submissions as required
- May provide technical interface with FDA and international reviewers and respond to questions
- Provide timely review and approval of product labeling and marketing claims for regulatory compliance
- Provide support required for CE marking activities, including preparation and maintenance of product technical files and clinical evaluations
- May supervise and direct Project Team personnel; may provide direction to assistant personnel
- IEC 60601 (electrical medical) and 62304 (software) experience is a plus
- Must have knowledge of the U.S. regulations and European medical device directive
- Must have excellent written and verbal communication skills
- Must be self-motivated by working independently and having the ability to take ownership of her/his responsibilities
- Must have experience in change assessments
- Must be able to prioritize and handle several projects concurrently
- Must have proficiency in technical writing and preparing documentation for appropriate audience
- Ability to provide leadership and mentoring skills to less experienced regulatory personnel is preferred
- Must be able to maintain confidentiality in dealing with regulatory and clinical documentation
EDUCATION and/or EXPERIENCE:
- BS in a scientific discipline with 2-5 years medical device employment in the areas of product registration, compliance or quality systems; or
- Combination of education and experience determined to be equivalent
- Regulatory Affairs Certification (RAC) preferred
- Capital equipment / electronic medical device experience a plus
- Must have proficient command of the English language - written & verbal
- Should have mathematical skills commensurate with educational background and necessary for describing and summarizing laboratory and/or clinical data in product registration submissions
- Must demonstrate the ability to plan and complete regulatory pathway determinations, product registration submissions and other documentation
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