The Program Director of International Regulatory Affairs reports directly to the BPV Director of Regulatory Affairs and will work closely with the Division and International Business Center (IBC) project teams in the development and execution of regulatory submissions.
Summary of Position with General Responsibilities:
The BPV Program Director of International Regulatory Affairs has the overall responsibility to develop, facilitiate and execute comprehensive Global regulatory strategies to accelerate and ensure successful product registrations for both new product launches and change management to commercialized product registrations.
Essential Job Functions:
Must be able to interpret and effectively deal with complex regulatory issues across business units in support of both division and corporate goals.
- Must possess excellent communication (both written and verbal), influential and negotiating skills, allowing the effective communication of complex regulatory information to a wide variety of audiences and leveraging for the best outcome.
- Must be a collaborative facilitator and leader, building consensus while championing global regulatory initiatives.
- Direct team of International Regulatory Affairs professionals to support Global product registrations.
- Where appropriate, manage GIF funded International RA project and report on a monthly basis to the Management Board on activities and progress.
- Using knowledge of Global regulatory requirements achieve strategies that focus on speed to market and successful submissions to obtain approval in an efficient timely manner.
- Analyze current processes, develop regulatory metrics and scorecards and institute data-based process improvements which will facilitate the product registration process and align with corporate and business unit goals.
- Develop and foster professional working relationships with Global regulators, as needed, and with industry associations (i.e. AdvaMed).
- Provide technical leadership and vision through the interpretation of new and emerging Global regulatory trends pertinent to the the business unit needs and implement strategies and projects to optimize regulatory performance in light of these trends.
The incumbent will have: • Evidence as a regulatory leader with a minimum of 15 years experience in a regulated health industry, with a strong concentration in medical devices.• Minimum of 10 years experience in senior regulatory affairs management responsible for Global registration of medical devices.• Significant experience interfacing with international regulatory authorities with a proven track record of numerous successfully completed medical device product approvals.• Capability of assuming the leadership for management and ownership of Global product registrations. • Excellent written and verbal communication along with strategizing and influential strengths. Must be able to manage by influence as the position has no direct reports but relies heavily on other units and divisions within the organization to achive goals & Ability to manage differences in international business cultures and standards along with language translations to obtain successful and timely product registrations.
Additional Desirable Qualifications Skills and Knowledge:
A bachelor’s degree in biological, health sciences or physical sciences. An advanced degree is preferred. Experience as a senior manager of within a large matrix-managed organization would be beneficial. Multilingual skills would be a benefit.
Education and/or Experience:
C. R. Bard is no upstart in the world of medical devices. The company has been in the business for more than a century and introduced the...