Job Description

The International Regulatory Affairs Specialist is responsible for collaborating with regional colleagues to develop strategies for moderately complex submissions to regulatory agencies worldwide. They interpret regulations and guidance's ex-U.S. and communicate to the country how these impact the ability to register. They coordinate and support worldwide product registration requests, interface with global international regulatory and marketing contacts to support regional registration requirements and develop/maintain department procedures for international product registrations. They assemble technical information according to registration requirements. They understand the regulations of the regions and how to meet their registration needs as well as the objectives of the business.

Responsibilities

• Coordinates and collects specific registration information with R&D, Manufacturing, QA, Medical and other applicable departments, as necessary to support registration requirements.
• Interfaces with OEMs to collect specific registration information.
• Assembles technical information to create a "clinical report" or a "dossier".
• Acts as lead for key countries, as identified, managing each request to completion.
• Recognizes and proposes continuous process improvements.
• Develops and maintains departmental procedures (SOP's and work instructions) for international product registrations.

Minimum Requirements

Education & Experience:

Bachelor's degree in Regulatory Affairs, Life Sciences, Biomedical Engineering, Pharmacy, or related scientific/technical discipline (Equivalent combination of education and relevant experience may be considered).

Technical & Functional Skills:

• Experience coordinating cross-functional inputs (R&D, QA, Manufacturing, Marketing)
• Ability to compile and review technical documentation in accordance with country-specific requirements
• Understanding of regulatory submission processes and lifecycle management

Communication & Collaboration:

• Strong written and verbal communication skills
• Experience working with global teams, regional affiliates, or distributors

Process & Compliance:

• Familiarity with SOPs, regulatory procedures, and quality systems (e.g., ISO 13485)
• Ability to identify and support process improvements

Other:

• Strong organizational skills and ability to manage multiple submissions/projects simultaneously
• Proficiency in Microsoft Office tools (Excel, Word, PowerPoint)

Preferred Qualifications

• Experience supporting international (ex-U.S.) regulatory submissions and product registrations
• Minimum 2-5 years of regulatory affairs experience, preferably in medical devices, pharmaceuticals, or healthcare products
• Regulatory Affairs Certification (RAC)
• Experience acting as country lead or project lead for registrations
• Exposure to OEM/private label compliance requirements
• Knowledge of UDI, labeling, and post-market regulatory activities

Preferred Regulatory Knowledge:

• Working knowledge of global regulatory requirements (e.g., EU MDR/IVDR, Canada, LATAM, APAC markets)
• Familiarity with technical documentation, dossiers, and clinical evaluation reports

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.

Primary Work Location

USA MD - Sparks - 7 Loveton Circle

Additional Locations

Work Shift

NA (United States of America)

At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You."

Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.

Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.

Salary Range Information

$75,800.00 - $121,300.00 USD Annual