Job Description Summary

Reporting to the Director, Medical Affairs BDPI, this role supports Medical Safety in review of the Peripheral Intervention (PI) risk documentation, specifically EU MDR-related documents. This includes, but is not limited to, Clinical Evaluation Reports (CER), Post-Market Clinical Follow up (PMCF) activities, as well as product Risk Management files required to have medical review and approval under the MDR regulation. Coordination and alignment on documentation reviews will occur between PI Medical Affairs management and the Medical Lead. Role can be 100% remote.

Job 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 ground-breaking 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.

Position Summary:

Reporting to the Director, Medical Affairs BDPI, this role supports Medical Safety in review of the Peripheral Intervention (PI) risk documentation, specifically EU MDR-related documents. This includes, but not limited to, Clinical Evaluation Reports (CER), Post-Market Clinical Follow up (PMCF) activities, as well as product Risk Management files required to have medical review and approval under the MDR regulation. Coordination and alignment on documentation reviews will occur between PI Medical Affairs management and the Medical Lead. Role can be 100% remote.

Essential / Key Job Responsibilities (including supervisory and/or fiscal):

• Provides guidance and expertise for clinical evidence substantiation, in context of PMCF and EU MDR requirements.

• Works with the corporate medical affairs organization to assist with the review and approval of CER, PMCF, and Risk Management File documents (FMEA, RBA, V&V Testing, etc.)

• Evaluates the clinical context for CER by reviewing peer reviewed journal manuscripts, data sheets, white papers, web copy, user guides and other technical communication materials.

• Ensures that accurate, high-quality documents are reviewed on schedule as per project timeline and workload demands.

Required Qualifications:

• NP/PA/RN or MD/DO credentials required.

• A minimum of 5 years of clinical experience is preferred, including interventional procedures.

• A minimum of 5 years industry experience in Medical Affairs within the biotech/medical device industry is preferred.

• Solid understanding and respect of FDA/EU MDR regulations and guidelines and other international regulatory requirements a plus.

• Interpersonal Skills - Able to establish and build close working relationships across a highly matrixed organization and with alliance partners. Strong personal credibility, written and oral communication skills. Accomplished in group, business, and social settings, respected by professional peers. Comfortable and capable in a variety of cultures and skilled in working internationally.

• Must be able to understand legally and technically written standards, regulations, procedures, test methods so as to communicate their intent.

• Must be able to organize, prioritize and work effectively in a constantly evolving environment.

• Availability to participate in early or late meetings/teleconferences.

• Knowledge of clinical study design, technical writing, and critical literature appraisal.

• Knowledge of product development and risk management processes would be an asset.

• Proven leadership skills.

• Proven capability for strategic thinking, excellent analytical and problem solving skills.

• Proven ability to understand, interpret and explain sophisticated clinical and scientific information.

• Strong communication skills (verbal, presentation, written).

• Travel up to 15%

Preferred Qualifications:

• MD or DO with medical device experience preferred.

• Role can be remote or located in Tempe, AZ.

Education and/or Experience:

• NP/PA/RN or MD/DO credentials required.

Physical Demands:

While performing the duties of this job, the employee is regularly required to stand, walk, sit, use sight, and use hands to manipulate, handle or feel objects, tools, controls, and office equipment. The employee frequently is required to verbally connect with other associates. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.

Work Environment:

While performing the duties of this job, the employee may be in an open cubicle environment. Candidate must be able to work in a team-oriented, fast-paced environment. BD is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.

This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.

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 phenomenal, we do what’s right, we hold each other accountable, and learn and improve every day.

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and exciting culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time. And through the organization’s investment in BD University, you will continually level up your tech skills and expertise.

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 creativity and aim to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place.

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

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status.

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Primary Work Location

USA AZ - Tempe Headquarters

Additional Locations

Work Shift