Sr Regulatory Affairs Specialist

Location: Bengaluru

Job Description Summary

Job Description  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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Primary Work Location IND Bengaluru - Technology Campus

Additional Locations

Work Shift