Job Description

Locations

• USA GA - Covington BMD

Skills Required

• Regulatory Affairs within the medical device industryintermediate
• preparingintermediate
• FDA regulationsintermediate
• regulatory information management systemsintermediate

Required Qualifications

• Bachelor's degree in a scientific or technical discipline (e.g., Biomedical Engineering, Chemistry, Biology) required. Advanced degree (MS, PhD) preferred. (degree in a scientific or technical discipline)
• Minimum of 8-10 years of experience in Regulatory Affairs within the medical device industry, with at least 3-5 years in a leadership or senior role. (experience, 10 years)
• Demonstrated expertise in preparing and submitting various regulatory applications (e.g., 510(k), PMA, CE Mark, International registrations). (experience)
• Strong knowledge of FDA regulations (21 CFR Parts 800s), ISO 13485, Medical Device Regulation (EU MDR), and other relevant international regulatory requirements. (experience)
• Excellent written and verbal communication skills, with the ability to effectively communicate complex regulatory information to diverse audiences. (experience)
• Proven ability to lead projects, manage multiple priorities, and work effectively in a fast-paced environment. (experience)
• RAC (Regulatory Affairs Certification) preferred. (certification)
• Proficiency in regulatory information management systems and tools. (experience)
• Bachelor's degree in a scientific or technical discipline (e.g., Biomedical Engineering, Chemistry, Biology) required. Advanced degree (MS, PhD) preferred. (degree in a scientific or technical discipline)
• Minimum of 8-10 years of experience in Regulatory Affairs within the medical device industry, with at least 3-5 years in a leadership or senior role. (experience, 10 years)
• Demonstrated expertise in preparing and submitting various regulatory applications (e.g., 510(k), PMA, CE Mark, International registrations). (experience)
• Strong knowledge of FDA regulations (21 CFR Parts 800s), ISO 13485, Medical Device Regulation (EU MDR), and other relevant international regulatory requirements. (experience)
• Excellent written and verbal communication skills, with the ability to effectively communicate complex regulatory information to diverse audiences. (experience)
• Proven ability to lead projects, manage multiple priorities, and work effectively in a fast-paced environment. (experience)

Preferred Qualifications

• Proficiency in regulatory information management systems and tools. (experience)
• At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. (experience)

Responsibilities

• Develop and implement comprehensive regulatory strategies for new product development, product
• life cycle management, and post-market surveillance activities.
• Prepare, review, and submit regulatory documents, including 510(k)s, Dossiers, Technical Files, and other international submissions to global health authorities.
• Act as the primary regulatory contact for assigned projects, communicating directly with regulatory agencies during submissions, reviews, and inspections.
• Interpret and apply complex regulations, guidance documents, and industry standards to ensure product compliance throughout the development and commercialization process.
• Lead and mentor junior regulatory affairs professionals, fostering a culture of compliance and continuous improvement.
• Participate in internal and external audits, providing regulatory expertise and support.
• Assess the regulatory impact of product changes, manufacturing changes, and quality system changes.
• Collaborate effectively with R&D, Quality, Clinical, Marketing, and other relevant departments to achieve regulatory objectives.
• Monitor and disseminate information regarding new or changing regulatory requirements and industry trends relevant to the company's product portfolio.
• Develop and implement comprehensive regulatory strategies for new product development, product
• life cycle management, and post-market surveillance activities.
• Prepare, review, and submit regulatory documents, including 510(k)s, Dossiers, Technical Files, and other international submissions to global health authorities.
• Act as the primary regulatory contact for assigned projects, communicating directly with regulatory agencies during submissions, reviews, and inspections.
• Interpret and apply complex regulations, guidance documents, and industry standards to ensure product compliance throughout the development and commercialization process.
• Lead and mentor junior regulatory affairs professionals, fostering a culture of compliance and continuous improvement.
• Participate in internal and external audits, providing regulatory expertise and support.
• Assess the regulatory impact of product changes, manufacturing changes, and quality system changes.
• Collaborate effectively with R&D, Quality, Clinical, Marketing, and other relevant departments to achieve regulatory objectives.
• Monitor and disseminate information regarding new or changing regulatory requirements and industry trends relevant to the company's product portfolio.

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