Sr Regulatory Affairs Specialist

P3-14314

Job Responsibilities:

• Represents Regulatory Affairs on product development teams to support new product development and change control to ensure US, EU, and other global regulatory requirements are met
• Evaluates medical device regulations and leads development of global regulatory strategies to bring products to market
• Reviews and approves design control documentation and product labeling in consideration of US, EU, and other global regulatory requirements
• Authors FDA submissions, EU technical files, and other regulatory documents for submission to regulatory bodies for product review and approval
• Leads interactions with FDA, EU notified bodies, and other regulatory agencies on submissions and other issues
• Independently reviews product changes to ensure regulatory compliance, including assessment of impact to US and CE Mark and prepares resulting notifications
• Communicates changes to global regions and supports preparation of global notifications as needed
• Understands fundamental global regulatory requirements and different regulatory pathways
• Stays informed of new regulations and changes to existing regulations and communicates to project teams
• Identifies and communicate appropriately quantified risks and mitigation strategies associated with regulatory changes to partners
• Maintains regulatory databases and systems
• Supports regulatory body audits, CAPAs, and other compliance activities
• Reviews advertising and promotional material
• Participates in claims development strategy
• Leads training related to areas of expertise
• Mentor other regulatory colleagues

Education and Experience

This position requires:

• Bachelor's degree or higher, preferably in a scientific discipline
• Master's degree in Regulatory Affairs preferred
• Regulatory Affairs Professional Society (RAPS) certification preferred
• Min 5 years Regulatory Affairs experience in the medical device industry
• Experience leading communications with FDA, EU notified bodies, and other regulatory agencies
• Experience with US 510(k), CE mark (EU MDD/MDR), and other international requirements and submissions
• Experienced in product development processes and design control.

Knowledge and Skills

• Excellent written and verbal communication skills including ability to communicate across culture work with others in team environment effective interactions with technical personnel (scientific and legal) and negotiate with Regulators.
• Excellent writing skills able to review and summarize scientific and technical information
• Strong negotiation skills
• Excellent communication and organization skills
• Excellent problem-solving skills
• Detail-oriented, with focus on accuracy and completeness
• Ability to manage multiple tasks and meet timeline commitments
• Ability to work in a team-oriented, fast-paced environment
• Demonstrated ability to analyze, interpret, and review scientific, technical, and regulatory information
• Comprehensive understanding of global medical device regulations, with in-depth knowledge of US and EU requirements
• Working knowledge of ISO 13485 and 21 CFR 820 quality system requirements.
• Ability to mentor and teach other regulatory associates
• Regulatory Subject Matter Expert
• Demonstrated self-starter, and highly motivated
• Ability to be effective in complex projects with ambiguity and/or rapid change
• Proficient in use of Microsoft Office tools (including Word, Excel, PowerPoint)

About BD
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics, and the delivery of care. The company develops innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD has 70,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.

About BD TCI
BD, a 125-year-old global medical device company, has started its Enterprise Center in Bangalore, India called BD Technology Campus India (TCI). This Enterprise Center will be an integral part of the global network for BDX. It will have presence of R&D, Quality, Regulatory, IT and other functions. The center boasts of some of the brightest minds who work in a unique environment that fosters and supports ingenuity. BD TCI is dedicated to serving BD's customers and patients thereby contributing towards BD's mission of .

Required Skills

Optional Skills

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