The Regulatory Affairs Specialist II is responsible for implementation of regulatory strategies including domestic and international submissions and other support of product project team with primary focus on EU MDR.
This position is a temporary assignment which will include benefits such as (medical, health, dental, 401k). Eligibility for these benefits will be based on the eligibility requirements as determined by the BD Total Rewards policy, and is anticipated to last approximately through September 30, 2023.
ESSENTIAL DUTIES AND RESPONSIBILITIES including the following. Other duties may be assigned.
- 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 and audit 510(k)s, IDEs, PMA and/or international submissions as required
- 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
- Must have knowledge of the U.S. and European medical device regulations
- 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 be able to prioritize and handle several projects concurrently
- Must have technical writing skills and be proficient at compiling successful submissions for the appropriate audience
- Must be able to provide leadership and mentoring skills to less experienced regulatory personnel
- Must be able to maintain confidentiality in dealing with regulatory and clinical documentation
EDUCATION and/or EXPERIENCE:
- BS in a scientific discipline with 3-5 years employment in the areas of product registration (or Regulatory with compliance or quality systems) or combination of education and experience determined to be equivalent
- Regulatory Affairs Certification (RAC) desired
Very competitive salary and benefits!
Great company to work for!
Full relocation package is available!
Don't miss out! Apply now and we'll be in touch immediately with more specific details, salary information and to answer any questions!!
This position does NOT provide sponsorship so please do NOT apply if you require sponsorship. Thank You
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