Job Description

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 RESPONSIBILITIESincluding 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 collaborate 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 provide training or direction to other regulatory team members

QUALIFICATIONS:

• 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 field with 3-5 years employment in the areas of medical device product registration. Combination of education and experience determined to be equivalent

• 2 or more years 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)

• Experience preparing and auditing 510(k)s, IDEs, PMA and/or international submissions

• Experience reviewing and approving product labeling and marketing claims for regulatory compliance

• Supporting CE marking activities, including preparation and maintenance of product technical files and clinical evaluations

• Previous experience training or direction to other regulatory team members

• Regulatory Affairs Certification (RAC) desired

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

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

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

For certain roles at BD, employment is contingent upon the Company27s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD27s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law

Required Skills

Optional Skills

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