Regulatory Affairs Specialist

Regulatory Affairs Specialist

The Regulatory Affairs (RA) Specialist provides primary RA support for one or more product line(s), region(s) and/or process/system. The RA Specialist may participate independently on new product development teams and provide continued RA support through the lifecycle of the product. The RA Specialist also prepares regulatory submissions required to market new or modified medical devices in global markets. The RA Specialist may also provide primary support for compliance processes, systems, or databases, including independent work on project teams to update or implement new systems, procedures. The RA Specialist is able to interpret and communicate regulatory issues to ensure the business is aware of opportunities, risks, and concerns.

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.

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

• Understands fundamental global regulatory requirements and different regulatory pathways.
• Understands scientific and health principles related to healthcare product development and regulations.
• Participates in core teams as regulatory lead and provides guidance on regulatory requirements to product development teams, with some support from management.
• Organizes materials from preclinical and clinical studies for review and assists in the review process.
• Assists and/or has ownership in preparation of dossiers and submission packages for regulatory agencies.
• Supports development of regulatory strategies for marketing authorization for domestic and/or global markets.
• Independently reviews product changes to ensure regulatory compliance, including assessment of impact to US and CE Mark and prepares resulting notifications. Communicates changes to global regions and supports preparation of global notifications as needed.
• Assists in the preparation and sending of post-market reports and submissions.
• Participates in training of colleagues, as needed, for areas of expertise.
• Demonstrates data interpretation skills to provide solutions, draw conclusions and identify trends.
• Understands relevant Quality System principles and processes and helps to ensure they remain up-to-date and compliant.
• Lead the development of processes, tools, and models related to RA work.
• Independently reviews advertising and promotional material for respective product line(s) and/or region(s) as needed.
• Maintains regulatory databases/systems with key regulatory data.
• Assists in the preparation and sending of system effectiveness reports and summaries related to regulatory systems and tools, as applicable.
• May participate in regulatory body audits, as related to respective product line(s) and/or region(s).

Ability to travel up to 25% of the time

Qualifications:

• Ability to plan and schedule multiple priorities in a concurrent fashion.
• Ability to review, collate, and summarize scientific and technical data.
• Ability to learn new technical concepts and skills.
• Good problem solving and analytical skills.
• Good written and oral communication skills.
• Previous experience in the medical device industry and/or experience in Regulatory Affairs.

Preferred Qualifications:

• Detail-oriented, methodical, and able to handle regulatory information and submissions with a high degree of accuracy.
• Ability to complete work with minimal supervision and ability to work independently.
• Previous experience in regulatory body audit support.
• Experience with regulatory tools and systems.
• Excellent writing and strong organizational skills.

Required Education and/or Experience:

• Bachelor's degree or advanced degree in technical area such as biology, chemistry, engineering or medical-related field and a minimum of one year of experience, or equivalent combination of related education and experience.
• Preferred minimum of two-to-four years of experience in the medical device industry, with two years in a regulatory role.

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 communicate with other associates. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch. Inability to meet one or more of these physical demands will not automatically disqualify a candidate or employee from the position. Upon request, the company may make reasonable accommodations.

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.

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.

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. 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.

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.

Primary Work Location: USA AZ - Tempe Headquarters

Additional Locations

Work Shift