Sr. Life Sciences / Regulatory Attorney
Location
Bethlehem, PA | United States
Job description
About B. Braun
B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap ® and CAPS ® .
Globally, the B. Braun Group of Companies employs more than 64,000 employees in 64 countries. Guided by its Sharing Expertise ® philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, visit .
Position Summary:
Braun Medical Inc. (“B.Braun”) 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.
The targeted range for this role takes into account a range of factors that are considered when making compensation and hiring decisions; included but not limited to: skill sets; experience and training; licensure and certifications; and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. Compensation decisions are dependent on the facts and circumstances of each case. The range provided is a reasonable estimate.
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$157,384 - $204,599
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.
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds.
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Responsibilities: Other Duties:
The preceding functions have been provided as examples of the types of work performed by employees assigned to this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this description are representative of the knowledge, skill, and/or ability required. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons.
Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate.
B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at
Through its “Sharing Expertise®” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.
Equal Opportunity Employer Veterans/Disabled
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