The primary responsibilities of this role, (Associate Director Global Regulatory Strategies Devices, Life Cycle Engineering), are to:
Develops and implements key global Regulatory strategies for key life-cycle/market expansion projects ensuring that Regulatory requirements are captured in global regulatory strategies and development plans, while balancing business objectives.
Develops and implements regional/local Regulatory project goals for key life-cycle/market expansion projects;
Leads and/or participates on Regulatory Affairs Teams and/or Global Project Teams;
Leads preparations and conduct/follow-up for meetings and teleconferences with US/Can/EU HA officials/Technical Bodies and aids in other country HA meeting preparation/conduct/follow-up;
Responsible for the preparation of key 510(k) and International LCE submissions as well as preparation and maintenance of technical documentation in compliance with the European Medical Device Regulations.;
Ensure submissions and technical documentation are consistent with the business strategy;
For key device LCE projects, develop regional/local submission/technical documentation materials, guide the review process, check for accuracy, technical consistency, compliance to local and global HA regulations and completeness of submission;
Clearly communicates recommended LCE strategies and changing local regulatory requirements, including necessary adaptions to peers, senior management and cross-functional teams;
Ensures assigned device compliance, including change management, with all applicable regulations and standards and proactively monitors the competitive landscape and advises the organization on actions to be taken with regard to opportunities or threats;
Proactively identifies regulatory issues/risks and designs/executes mitigation plans;
May act as a company liaison to industry trade associations;
Review and suggest possible organization reaction to new or proposed legislation;
Develop and enact Regulatory strategies and plans in support of key product supply projects;
May work on assigned special projects such as contributing to Regulatory Affairs functional improvement initiatives;
The incumbent should be capable of performing these tasks with minimal supervision.
WHO YOU ARE
Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:
Languages Required: English
Ph.D., M.D., P.Eng. or PharmD with a minimum of 4 years of Regulatory device experience; or a Master's with a minimum of 6 years of Regulatory device experience; or a Bachelor's degree with a minimum of 8 years of Regulatory device experience;
Strong familiarity and hands-on experience working with medical device regulations;
Working knowledge of Quality System Regulations;
Experience in FDA and EU medical device 510(k)/technical documentation requirements;
Ability to articulate and solve regulatory device issues independently;
Ability to communicate and negotiate effectively in English both verbally and in writing;
Team and customer orientation.
The successful candidate will display:
Strategy and results orientation;
Ability to experiment;
Business acumen and commercial orientation.
Internal Number: 47574
Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.