Job Description Summary

Job Description

Bachelor's degree or higher, preferably in a scientific discipline
Master's degree in Regulatory Affairs preferred
Regulatory Affairs Professional Society (RAPS) certification preferred
6-8 years Regulatory Affairs experience in the medical device industry

>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 knowlege of US and EU requirements 
>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
>Working knowledge of ISO 13485 and 21 CFR 820 quality system requirements.
>Experienced in product development processes and design control.
>Mentor/teach/SME
-Demonstrated self-starter, and highly motivated
-Excellent writing skills; able to review and summarize scientific and technical information
-Strong negotiation skills 
-Ability to be effective in complex projects with ambiguity and/or rapid change
-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.
>Proficient in use of Microsoft Office tools (including Word, Excel, PowerPoint)

The Staff Regulatory Affairs Specialist independently supports projects to bring new and modified medical devices to market and ensure ongoing compliance. They participate on cross-functional teams, lead the development of global regulatory strategies, author regulatory submissions, lead interactions with regulatory agencies/notified bodies, review design control documents and product labeling, and evaluate proposed device changes. The Staff Regulatory Affairs Specialist is able to interpret and communicate regulatory issues to ensure the business is aware of opportunities, risks, and concerns, and provides recommendations to minimize risk.

>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
>Mentors other regulatory colleagues

While performing the duties of this job, the employee is regularly required to stand, walk, sit, use sight, and use hands to manipulate, handle or feel objects, tools, controls, and office equipment. The employee frequently is required to verbally communicate with other associates. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.  Inability to meet one or more of these physical demands will not automatically disqualify a candidate or employee from the position.  Upon request, the company may make reasonable accommodations.
Candidate must be able to work in a team-oriented, fast-paced environment. BD is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.

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