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Regulatory Affairs Specialist
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 www.BBraunUSA.com.
Responsibilities: Essential Duties
- Plans and prepares registration documents for marketing approval of drug and device products in the US and in foreign countries.
- Serves as a regulatory liaison for new product development and make regulatory assessments of proposed changes to existing products for impact to regulatory documentation.
- Provides strategic input and guidance to project teams in conjunction with supervisor.
- Plans and prepares dossiers for registration of drug and device products.
- Independently reviews and analyzes proposed modifications to drug and device products for regulatory impact.
- Independently reads, reviews, interprets and keeps current with regulations and publications regarding drug and device products and communicate within the department.
- May oversee and direct the work of other Regulatory Affairs professionals.
Expertise: Knowledge & Skills
- Requires full working knowledge of relevant business practices and procedures in professional field. Uses standard theories, principles and concepts and integrates them to propose a course of action.
- Work under minimal supervision. Relies on experience and judgement to plan and accomplish assigned goals. May periodically assist in orienting, training, assigning and checking the work of lower level employees. Referring only complex problems and issues
- Judgement is required in resolving complex problems based on experience.
- Contacts are primarily with department supervisors, leads, subordinates, and peers. Occasional contact with external contractors/vendors.
Expertise: Qualifications -Education/Experience/Training/Etc
- Bachelor’s degree required.
- 02-04 years related experience required.
- Applicable industry/professional certification preferred.
- Regular and predictable attendance
- Occasional business travel required
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.
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
- Occasionally:Climbing stairs/ladders, Push/pull, Reaching upward and downward, Standing, Walking
- Frequently:Finger feeling, Hearing – ordinary, fine distinction, loud (hearing protection required), Seeing – depth perception, color vision, field of vision/peripheral, Sitting , Talking – ordinary, loud/quick
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:Moderate
- Constantly:Office environment
What We Offer
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.
Job posted: 2022-07-10