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BD (Becton, Dickinson and Company) Director, Regulatory Affairs, Molecular Diagnostics and Women’s Health & Cancer - Integrated Diagnostics Solutions in Baltimore, Maryland

Job Description Summary

This position provides regulatory leadership to the BD Integrated Diagnostic Solutions unit as a member of the MDx/WHC Leadership Team. Contributes to the development of BD’s MDx/WHC platform strategy and operational plans through sound assessments of regulatory pathways and risks. Such assessments may influence the scientific or technical direction of product design and/or development. Directs functional activities designed to achieve rapid worldwide clearance/approval/registration of BD products with desired claims. Represents BD’s MDx/WHC interests in pivotal interactions/negotiations with U.S. regulatory agencies and plays an active role in external efforts to develop standards of strategic importance to BD and to influence policy-making bodies.

Partners with Marketing, Business Development, and other business leaders to create unique market entry and sustainability strategies while maintaining strict regulatory compliance. Works with various BD partners in the development of products for use on BD systems. Critical thinking, strategic agility and dealing with ambiguity are key skill sets for this role.

Leads and develops a talented team of managers and individual contributors towards achieving aggressive business goals. This function is responsible for regulatory functional excellence, including overall regulatory strategy, operations, and talent management. Regulatory operations include systems for managing FDA Class III post-market management and RA department document management systems.

This position also establishes the regulatory affairs operating plan for the MDx/WHC portfolios and drives the efficient delivery of high quality regulatory submissions that shorten time to market and provide competitive advantage.

The Director, Regulatory Affairs, MDx/WHC also acts as the IDS MDx/WHC Portfolio Decision Teams (PDTs) representative

Job Description

JOB DESCRIPTION SUMMARY:

Director, Regulatory Affairs – Molecular Diagnostics (MDx) and Women’s Health & Cancer (WHC) reports directly to the Vice President, Regulatory Affairs - Integrated Diagnostic Solutions (IDS). Primary office location is 7 Loveton Circle Sparks, MD with flexibility to be Remote.

This position provides regulatory leadership to the BD Integrated Diagnostic Solutions unit as a member of the MDx/WHC Leadership Team. Contributes to the development of BD’s MDx/WHC platform strategy and operational plans through sound assessments of regulatory pathways and risks. Such assessments may influence the scientific or technical direction of product design and/or development. Directs functional activities designed to achieve rapid worldwide clearance/approval/registration of BD products with desired claims. Represents BD’s MDx/WHC interests in pivotal interactions/negotiations with U.S. regulatory agencies and plays an active role in external efforts to develop standards of strategic importance to BD and to influence policy-making bodies.

Partners with Marketing, Business Development, and other business leaders to create unique market entry and sustainability strategies while maintaining strict regulatory compliance. Works with various BD partners in the development of products for use on BD systems. Critical thinking, strategic agility and dealing with ambiguity are key skill sets for this role.

Leads and develops a talented team of managers and individual contributors towards achieving aggressive business goals. This function is responsible for regulatory functional excellence, including overall regulatory strategy, operations, and talent management. Regulatory operations include systems for managing FDA Class III post-market management and RA department document management systems.

This position also establishes the regulatory affairs operating plan for the MDx/WHC portfolios and drives the efficient delivery of high quality regulatory submissions that shorten time to market and provide competitive advantage.

RESPONSIBILITIES:

  • Provides regulatory leadership to BD’s MDx/WHC platform teams and the MDx/WHC Leadership Teams. Works closely with leadership team members to ensure alignment of regulatory strategies with business objectives.

  • Assesses regulatory pathways for new product platforms and product modifications; develops regulatory strategies and tactical plans for submissions to FDA and other global regulatory agencies.

  • Communicates potential risks and mitigations associated with regulatory strategies to stakeholders

  • Represents BD in interactions/negotiations with U.S. regulatory agencies and enables and empowers staff to interact and negotiate with regulators as well.

  • Represents BD’s MDx/WHC interests in external activities benefiting BD, including trade associations, professional organizations, and standards development organizations.

  • Manages and develops a staff of regulatory professionals carrying out product submission/registration activities. Assesses resource requirements based on business priorities and allocates personnel as required to meet these objectives. Aligns right capabilities to challenging tasks and continually monitors and measures with definitive metrics.

  • Clearly defines and articulates performance goals, with assigned accountabilities, clear decision authority, and an intense focus on alignment.

  • Actively identifies diverse slates of “high-potentials” and intentionally plans for their development (i.e., moves, assignments and skills development) through a well-planned and timed set of experiences and learnings.

  • Proactively promotes inclusion as a critical component of overall talent agenda for their areas of responsibility.

  • Continually demonstrates the ability to utilize both control and influence to drive results.

  • Directs the preparation and filing of premarket submissions [510(k)s, de novo submissions, PMAs and Technical Files], and the preparation of content for other ex-U.S. registrations.

  • Oversees FDA Class III post-market management processes and the operations of RA department document management activities.

  • Monitors global regulatory developments affecting BD’s MDx/WHC programs and products and communicates emerging opportunities and concerns to stakeholders.

  • Manages the regulatory review of labels, labeling, and promotional materials and sets policies to ensure consistency in these reviews.

  • Develops direct reports to required competencies, including, but not limited to regulatory knowledge and ability to apply this knowledge, effectiveness in team and one-to-one interactions, as well as verbal and written communications.

  • Designs and implements training on regulatory issues for staff and for business stakeholders (e.g., Marketing, Sales, Medical Affairs, and R&D).

  • Develops best-in class-functional processes. Ensures functional skills and competencies are reinforced with appropriate tools, templates, and metrics that are integrated into the product development processes.

  • Always thinks globally and acts locally with cultural sensitivity and organizational savvy.

  • Continually works and leverages the power of the matrix.

  • Acts as the IDS MDx/WHC Leadership Teams and MDx/WHC Portfolio Decision Teams (PDT) representative.

QUALIFICATIONS:

EDUCATION:

B.S. or B.A. degree in a technical discipline (biology, microbiology, or molecular biology).

RAPS RAC (U.S.) preferred.

EXPERIENCE:

Minimum ten years of directly related experience in increasingly responsible positions in the IVD/medical device field, and five or more years of management experience. Experience should include demonstrated success in developing systems for preparation and filing of complex IVD or medical device submissions (both U.S. and international), as well as negotiating favorable regulatory strategies and timely approvals. Advocacy work with trade associations and coalitions is preferred.

SPECIAL SKILLS:

  • Ability to think strategically, to detect the essence of complex or ambiguous issues, and to put these in the context of larger, systemic issues.

  • Strong business orientation - ability to communicate and interact effectively with senior BD business leaders in U.S. and around the world.

  • Demonstrated success in filing and completing (including negotiations) a significant number of complex regulatory submissions/dossiers [e.g., 510(k)s, IDEs, PMAs, EU Technical Files].

  • Must inspire, motivate, and build the confidence of teams to reach goals, steadfastly pushing self and others to achieve results.

  • Demonstrate leadership courage through openness to diverse views, candor in assessing and articulating difficult positions, and willingness to make changes when needed.

  • Demonstrate success in supporting both growth and product support projects, including complex projects involving ambiguity, in a rapidly changing regulatory environment.

  • Experienced in meeting with, making presentations to, and negotiating with regulators.

  • Demonstrated success in developing strong working relationships with regulators and external groups (e.g., trade associations) to effectively influence and bring about consensus on policies that support business objectives.

  • Ability to attract, recruit, mentor, and retain high-caliber professionals.

KNOWLEDGE OF SPECIFIC PROCEDURES/PRACTICES:

Comprehensive knowledge of regulatory requirements and strategies applying to medical devices and in vitro diagnostic devices in the U.S., EU, Canada, Japan, Asia Pacific, and Latin America. Must be able to interpret regulatory requirements, determine what is necessary for compliance, and effectively communicate this information to stakeholders.

Employment at BD is contingent upon the Company’s receipt of sufficient proof that you are or will be fully vaccinated against COVID-19. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Primary Work Location

USA MD - Sparks - 7 Loveton Circle

Additional Locations

Work Shift

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.

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.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com

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