Regulatory Affairs Specialist II

Description

We are the makers of possible

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the creativity and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.

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 collaborate with FDA and international reviewers and respond to questions

Provide timely review and approval of product labeling and marketing claims for regulatory compliance

Update STED technical files for CE marking activities and notified body interaction to accomplish EU / MDR product

May direct Project Team personnel; may provide direction to assistant personnel

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 their 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 maintain confidentiality in dealing with regulatory and clinical documentation

EDUCATION and / or EXPERIENCE :

BS in a Scientific field with 3-5 years of validated experience in the areas of product registration, compliance or quality systems; or a combination of education and experience determined to be equivalent. Experience with software and capital systems is a plus.

Regulatory Affairs Certification (RAC) desired

At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under “Our Commitment to You”. The anticipated compensation range for this position is $73,300.00 - $121,000.00 USD Annual and the compensation offered will depend on the candidate’s qualifications.

• BD follows the Pay Transparency and non-discrimination provisions described by the Colorado Department of Labor and Employment (CDLE).

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 Company’s 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 BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health.