Description:

Position Summary:
A German Medical and Pharmaceutical Device Company has an opening for a Senior Counsel, Life Science Regulatory and Quality. The Senior Counsel, Life Science Regulatory and Quality, will support a wide variety of global regulatory and quality matters related to the design, manufacture, distribution and sale of medical devices and pharmaceuticals throughout the world, including product submissions, premarket activities, marketing and promotion, quality system regulation, manufacturing activities, field corrective actions, clinical trial agreements and labeling requirements. This role will work closely with members of B. Braun's international regulatory, quality, legal and compliance teams ,to drive overall global strategy, improvements and risk mitigation, and other key initiatives. B.Braun is a member of the global B. Braun group of companies.

Responsibilities: Essential Duties

Provide legal guidance regarding FDA regulations relating to medical device and pharmaceutical product submissions; regulatory strategy and pre-market applications, including 510(k)s and PMAs; manufacturing and post-market requirements, including field corrective actions, CAPAs, and complaint handling
Provide solutions-oriented and strategic legal advice relating to B. Braun's interactions with FDA and other regulatory authorities.
Provide legal guidance in preparation for audits and inspections by the FDA, and in responding to FDA 483s and enforcement investigations and/or actions.
Review and provide legal advice on labeling, advertising and promotional materials.
Provide legal support in the development and implementation of policies, procedures, product manuals, legal guidance documents, and training materials as well as trainings of personnel, on FDA regulatory and quality matters.
Draft, review and negotiate agreements for the quality, regulatory and medical affairs departments, including but not limited to, quality agreements, clinical trial agreements, services agreements, material transfer agreements and research agreements. Provide legal advice to sales, marketing, finance, procurement and other departments to develop and refine regulatory and quality contract terms.
Work closely with members of B.Braun's international regulatory, quality, legal and compliance teams.
Coordinate with litigation team members as needed on product liability counseling.
Work closely with Corporate Compliance on anti-kickback, off-label marketing, physician payment, and patient privacy matters.
Monitor legislation, regulations, case law, and government oversight activities relating to FDA regulatory and quality issues and provide proactive, strategic advice.

Expertise: Knowledge & Skills

Strong attention to detail
Ability to handle multiple, competing workloads with changing priorities to meet necessary deadlines
Ability to effectively work with all levels of the organization
Handle long-term and/or complex legal projects with significant financial or other business impact
Strong business and financial acumen as well as superior analytical and writing skills.

Qualifications:
Expertise: Qualifications - Experience/Training/Education/Etc
Required:

JD Degree from a U.S. Accredited law school
Admission to at least 1 U.S. state bar or District of Columbia
8+ years of FDA life science regulatory and quality experience - at a top tier law firm and in an in-house legal organization
Strong expertise in U.S. federal and state medical device and/or pharmaceutical legal, regulatory and quality environments, including end-to-end support of regulatory approvals, post-market activities, quality management systems, sales and distribution, advertising and promotion, product clinical claims and manufacturing processes.
Knowledge of FDA medical device and pharmaceutical laws, regulations, and guidances, anti-kickback laws, false claims act, foreign-corrupt practices act, Physician Payments Sunshine Act, HIPAA, and related industry guidances.
Experience working with international regulatory, quality and legal teams in connection with the Essential Duties described above.
Demonstrated leadership responsibility involving all aspects of legal support of quality and regulatory matters, including the matters referenced above
Business Acumen - Understanding of basic business concepts, strategies, and risks
Analytical Skills - Excellent judgment, strategic and analytical thinking and the ability to assess risk and mitigations and make recommendations based on the company's values, vision, business goals and risk appetite
Innovation - Strong problem-solving/creative skills that drive new business solutions
Project Management - Strong priority-setting skills, attention to detail and the ability to work on multiple projects at the same time
Communication - Excellent verbal and written communication skills to allow effective interaction with all levels of the organization
Growth Mindset – Possesses a growth mindset with a passion for learning new things
Collaboration – Ability to thrive in a team environment
Diversity & Inclusion - Fosters a diverse and inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives

Desired:

Experience providing legal advice regarding environmental, health, safety and security regulations and practices at U.S. manufacturing facilities.
Experience providing legal advice related to pharmacy compounding under 503A and 503B of the Food, Drug & Cosmetic Act.