Manager, Regulatory Affairs

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 www.bbraunusa.com

Position Summary:

Responsibilities: Essential Duties

• Plans, directs, and monitors regulatory affairs activities so that the organization has the permits, licences, certificates, authorizations, and other approvals it needs to conduct its current and future business activities; and produce, sell, and distribute its goods and services.
• Oversees the most difficult, complex, or large application processes so that the organization submits a full and accurate application that is likely to be successful.
• Liaises with functional and operational area managers to understand their short to medium* term business goals (for example introducing a new product, service, or operating process or entering a new market) and develop plans, cost estimates, and schedules for acquiring the necessary permits and other approvals.
• Monitors regulatory and industry developments and advise senior management on the potential impact of current and future regulations on the operation of the organization.
• Establishes and maintains positive relationships with government agencies and other regulatory authorities; represent the organization in matters before regulatory, legislative, or industry standards agencies so that the organization's iterests are advanced.
• Prepares materials for legal counsel or external consultants and manage these relationships to ensure the organization's interests are well represented.
• Leads, directs, evaluates, and develops a team of regulatory affairs professionals to ensure that the organization's regulatory affairs activities are conducted accurately, ethically, and according to relevant regulations, laws, and standards.

Expertise: Knowledge & Skills

• Requires advanced knowledge of professional field and industry. Influences the development of and drives the application of principles, theories, concepts. Determines best course of action.
• Manages entry to intermediate level employees of a department or a function with 1 or 2 sections. Ensures budgets, schedules, and performance requirements are met.
• Judgement is required in resolving complex problems based on experience.
• Interacts with internal and/or external clients and customers to negotiate and interpret information on projects and unit operations. May consult with senior management.

Expertise: Qualifications -Education/Experience/Training/Etc

Required:

• Bachelor's degree required, Master's degree preferred.
• 06-08 years related experience required.
• Applicable industry/professional certification preferred.
• Regular and predictable attendance
• Occasional business travel required, Valid driver's license and passport, Secrecy and invention agreement and non-compete agreement, Ability to work non-standard schedule as needed

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.

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:

While performing the duties of this job, the employee is expected to:

• Light work - Exerting up to 20 lbs of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects.

Lifting, Carrying, Pushing, Pulling and Reaching:

• Occasionally:Reaching upward and downward, Push/pull, Stand, Visual Acuity with or without corrective lenses
• Frequently:Sit
• Constantly:N/A

Activities:

• Occasionally:Hearing - ordinary, fine distinction, loud (hearing protection required), Reaching upward and downward, Seeing - depth perception, color vision, field of vision/peripheral, Standing, Talking - ordinary, loud/quick, Walking
• Frequently:Finger feeling, Sitting
• Constantly:N/A

Environmental Conditions:

• Occasionally:Proximity to moving parts, Exposure to toxic or caustic chemicals (in most areas)
• Frequently:N/A
• Constantly:N/A

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.

• Noise Intensity:Low
• Occasionally:N/A
• Frequently:N/A
• Constantly:Office environment

$120,000-$130,000

#LI #MSL

Comprehend, analyze and interpret scientific/engineering data and product infromation in the context of regulatory intelligence and the current regulatory environment.

Develop amd implement complex regulatory strategies.

Manage regulatory activities for product lines/programs.

Serve as subject matter expert (SME) for area(s) of responsibility.

Provide strategic guidance to stakeholders.

Draft well written medical device submissions (presubs, DeNovo Requests, 510(k)'s, EU MDR Technical Files including correspondence and other project related documentation.)

Interact with Health Authorities of the US, Canada and EU (i.e. FDA, Health Canada and Notified Bodies.

Provide guidance to stakeholders on product lifecyle activities (e.g. launch, post market surveillance, change control modifications, annual reports, labeling, obsolesence.)

Train and mentor junior colleagues.

Keep current with science/engineering, the regulatory environment, products and industry trends. Actively participate in industry groups (AAMI, MDMA, Advamed, RAPS, etc.)

It is the duty of every employee to take reasonable care for safety and health of himself/herself and others while at work.

The job function is not exhasutive and also shall include any responsibility assigned by management from time to time.

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.

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 www.bbraunusa.com.

Through its "Sharing Expertise" initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.

We are an equal opportunity employer. We evaluate applications without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected characteristic. Know Your Rights: Workplace Discrimination is Illegal, click here.