Senior Regulatory Affairs Specialist

Becton Dickinson; Salt Lake City (UT); Hybrid; USD 110,000 - 140,000; Full time

Job summary

BD, a leading medical technology company, seeks a Senior Regulatory Affairs Specialist to drive regulatory submissions and global strategy for medical devices. You will collaborate with R&D, Quality, Manufacturing and other functions to ensure compliance and timely market access.

The role focuses on drafting regulatory submissions, maintaining registrations, and guiding product teams through FDA and EU regulations.

Qualifications

• Bachelor's degree in engineering, bioengineering, biology, chemistry, or health science.
• At least 3 years of regulatory experience in the medical device industry.
• Familiar with FDA, EU MDR 2017/745, ISO 13485; proven track record with FDA/Notified Bodies.

Responsibilities

• Support FDA 510(k) submissions and other FDA documentation.
• Prepare CE marking technical files with input from R&D, Quality, Manufacturing, etc.
• Submit notifications about significant changes to registered products to various geographies.
• Interact with reviewers from health agencies to respond to information requests.
• Review labeling to ensure regulatory compliance.
• Assist in developing and updating clinical evaluation reports for regulatory submissions.

Skills

Regulatory experience

Project management

Communication skills

Attention to detail

Education

Bachelor's degree

RAC – Regulatory Affairs Certification

Tools

RIMS

MS Office

Job description

We are the people who give possibilities purpose 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 imagination 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.

Job Description

At BD, we offer an outstanding chance for a Senior Regulatory Affairs Specialist to join a world-class team preparing regulatory submissions vital for marketing medical devices internationally. This role ensures that product development processes fulfill all regulatory demands and business objectives. You will play a key part in crafting the future of medical technology.

Responsibilities

• Provide support for FDA Premarket Notification [510(k) ] submissions and/or other FDA documentation formats in a timely manner.
• Prepare technical files for CE marking with appropriate input from various functions (R&D, Quality, Manufacturing, etc.) promptly.
• Submit notifications about significant changes to registered products to numerous geographies, including 'non-filing' justifications to EU Notified Body.
• Interact with reviewers from health agencies to respond to additional information requests during submissions.
• Review and authorize labeling to ensure Regulatory compliance.
• Assist in developing and updating clinical evaluation reports to ensure the gathering of suitable data for Regulatory submissions and adherence.
• Represent Regulatory Affairs in worldwide product life cycle development teams by reviewing, approving, and completing requirements of change control projects.
• Coordinate and collect specific registration information with R&D, Manufacturing, QA, Medical, and other applicable departments.
• Provide Regulatory mentorship throughout the product development cycle and coordinate team input.
• Submit product listings to the FDA.
• Support international registrations related to product changes, new product launches, and/or product renewals.

This role is working onsite hybrid, 4 days a week in Salt Lake City.

Required Qualifications

A Bachelor's degree, preferably in engineering, bioengineering, biology, chemistry, or health science.

At least 3 years of regulatory experience in the medical device industry.

Familiarity with a variety of medical device standards and regulations, including FDA, EU MDR 2017/745, ISO 13485 Proven record of guiding products through FDA, EU Notified Bodies, and/or other worldwide governing health authorities.

Practical understanding of 510(k), MDR 2017/745, and other global regulations.

Preferred Qualifications

Experience with vascular access devices.

RAC – Regulatory Affairs Certification.

Experience with Regulatory Information Management Systems (RIMS) Skills.

Proficient in using Microsoft Office.

Strong communication and project management skills.

Must be able to balance multiple tasks with minimal managerial oversight.

Attention to detail.

Ability to learn and grasp oftentimes complex concepts quickly.

The Sr. Regulatory Affairs Specialist independently supports projects to introduce new and updated medical devices to the market while ensuring ongoing compliance. They join cross-functional teams, lead the creation of global regulatory strategies, write regulatory submissions, engage with regulatory agencies and notified bodies, review product development documents and labeling, and assess proposed device modifications. The Sr. Regulatory Affairs Specialist interprets and communicates regulatory issues to keep the business informed of opportunities, risks, and concerns, offering recommendations to reduce risk.

Join us at BD and help build the future of medical technology by successfully implementing global regulatory strategies and ensuring flawless compliance with regulatory requirements!

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?

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 healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive. We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

To learn more about BD visit https://bd.com/careers.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.

Required Skills Optional Skills .

Primary Work Location USA UT - Salt Lake City BAS Additional Locations Work Shift We are the #MakersofPossible Working together, we make products that patients, families and their healthcare professionals rely on. We do this because we are committed to advancing the world of health™. But it takes the imagination and passion of all of us at BD, from manufacturing to marketing, to look at the impossible and find solutions that turn dreams into possibilities with real-life health benefits for people today, tomorrow and beyond. We make this happen, together. We are the makers of possible. Becton, Dickinson and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics.