Director, Regulatory Affairs

The Director, Regulatory Affairs works in cooperation with the VP, Regulatory & Clinical Affairs to manage development of global regulatory strategies and organizational development initiatives within Regulatory Affairs that achieve long term business goals. Provide strategies and infrastructure management support for BMT US and EU regulatory and Quality Management System (QMS) submissions for BMT product lines. Implement process improvement initiatives that will lead to higher levels of department efficiency and overall output. Align with cross-functional management to support new product development, product launch and product life cycle management and corporate objectives. Devote a significant portion of time to the management, leadership and development of a team of professionals responsible for regulatory and QMS support.

* Manage and coordinate the day-to-day activities of Regulatory Affairs staff focused on regulatory support for geographies such as US, EU, Canada, China, and Japan.

* Establish project priorities, allocate resources and workload.

* Provide technical guidance to team during the course of strategy formulation, submission preparation and interaction with regulatory bodies.

* Support external audits as required to maintain product approvals with regulatory authorities.

* Review and edit submissions prepared by staff.

* Promote employee development and foster growth of employees through:

o Performance Management

o Skills development

o Continuous one-on-one feedback

o Bi-annual appraisal of individual performance

o Recognition and motivational techniques/tools to drive high levels of employee performance and engagement

* Oversee and/or conduct training and mentoring of new and existing employees and facilitate assimilation of new members and changes

* Monitor resource requirements (human, equipment, etc.) and adjust team allocation, capability, and capacity to support growth projections and business initiatives.

* Collaborate cross-functionally with R&D, Clinical, Quality, and Operations to achieve optimal results in support of business needs.

* On occasion, this individual may temporarily assume leadership of Regulatory Operations, Technical Writing, or Clinical Affairs to ensure business continuity.

* Manage and implement regulatory submission strategies for new and modified BMT products in US and EU. Manage and support new worldwide regulatory submissions (including product approval, reimbursement approval and QMS). Manage and support maintenance of all approvals, including those related to product changes.

* Represent Regulatory Affairs at management business updates.

* Provide regulatory status updates to management.

* Review strategic submission materials.

* Act as company representative, developing and maintaining positive relationships with worldwide regulatory bodies and medical device reviewers regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow up of submissions under review.

* Maintain internal regulatory file documentation.

* Oversee Review and approval of product and manufacturing changes for compliance with applicable regulations.

* Serve on Business Unit leadership teams and actively participate in other cross-functional initiatives to foster a culture of customer focus, collaboration, sustainability, and project execution across BMT.

* Monitor regulatory environments worldwide and provide management with assessments of the impact of new or revised regulations.

* Develop and implement new regulatory policies, processes and SOPs and train key personnel to them.

* Establish and support a work environment of continuous improvement that supports Quality Policy, Quality System and the appropriate regulations for the area supported.

* Establish and maintain relationships with cross-functional departments including consultants and vendors.

* Plan and manage the departmental budget in collaboration with the VP of Regulatory and Clinical Affairs.

* Bachelor's degree in Science, Engineering, or equivalent discipline.

* 9+ years' medical device and/or pharmaceutical industry experience, including at least 7 years in Regulatory Affairs including strong 510(k) submission experience, EU CE Mark submissions, Health Canada submissions, and international market submissions.

* 5+ years supervisory experience and experience leading teams within a regulatory or quality function.

* Expert knowledge of and experience with quality systems regulations and guidelines, ISO, GMP, EU Medical Device Regulation (EU MDR) and Medical Device Directive (EU MDD), and Canadian Medical Device Regulations, Japanese PAL, 21 CFR Part 11 and other FDA and international regulatory requirements.

* Knowledge of global adverse event reporting requirements.

* Excellent interpersonal skills to enable effective interaction across all levels of the organization.

* Ability to clearly and concisely articulate ideas both verbally and in writing.

* Demonstrated project management skills in order to plan, conduct and implement system assessments and projects.

* Experience anticipating and adapting to changes in the external environment.

* Skilled in risked-based decision making.

* Proven success working collaboratively as part of a team in a fast-paced environment.

* Ability to travel both domestically and internationally.

Preferred:

* Basic knowledge and experience obtaining worldwide reimbursement

Other:

* Global travel required up to 20%

Compensation & Total Rewards:

Estimated Starting Salary Range: $195,000 - $210,000

*Estimated Starting Salary Range is reflective of the range Bracco Medical Technologies reasonably expects to pay for the position. The range provided is based on salary and market data specific to the position.

Total Rewards:

• Paid Time Off, Company Holidays & Paid Family Leave - We provide PTO and Company Holidays to help you recharge, relax and do what's important to you, when it's important to you. Our 100% paid family leave options for parents, grandparents and eligible family members provide support for growing families as well.
• Achieve - Beyond competitive compensation, we offer options to help you plan for a financially secure future, including an annual incentive plan and 401k savings plan contributions.
• Live well - We offer comprehensive benefit options to help protect you along the way, including medical, dental, vision, and life insurance, employer HSA contributions, employee assistance program, short-term disability, etc.
• Evolve - Through structured on-the-job learning, workshops, seminars, and our tuition reimbursement program, you'll find many opportunities to grow, personally and professionally.
• Choose - You won't find "stuffy" here-whether your position requires a hybrid or in-the-office working arrangement. That means business casual for your attire and flexibility in your schedule, wherever possible.