The primary responsibilities of this role, Regulatory Affairs International Strategist-Radiology Medical Device, are to:
Implement regulatory strategies through coordination and preparation of submission documents for the registration of new products and changes to existing products in international markets (i.e. Asia Pacific, Latin America, Middle East, Africa and Europe) in partnership with other International Specialists;
Maintain interactions with departments that are outside of Regulatory Affairs (Local Country and Business Unit Regulatory Affairs, Marketing, Legal, Medical/Clinical Affairs, Product Development, Supply Chain, etc.) to help manage complex negotiations with global regulatory authorities as needed through the local Regulatory Affairs (RA) representatives;
Collect, organize, maintain and archive regulatory authority market clearance and product registration documentation;
Act as a liaison with third-party distributors and/or Regulatory personnel within the Bayer affiliate locations to address questions and issues that arise as part of the registration process;
Work cross functionally with various businesses in Medical Care;
Support Bayer Radiology worldwide product registrations by preparing and coordinating regulatory submissions;
Ensure timely registration of products in compliance with applicable regulations and guidance;
Maintain up-to-date knowledge of global regulations;
Maintain country specific site registration requirements;
Contribute to the maintenance of the current regulatory databases to ensure accurate regulatory data;
Liaise with RA leads for new product development or line extensions;
Provide Regulatory guidance on the impact of post-market product changes and device modifications;
Provide Regulatory oversight of changes in manufacturing facilities, processes, and procedures, as these changes pertain to international regulations;
Collaborate with Bayer Radiology Regional regulatory representatives to understand local regulations.
Domestic relocation assistance is offered for this position
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:
Ph.D. with three (3) plus years of healthcare industry experience, Master’s degree with five (5) plus years of healthcare industry experience, Bachelor’s degree with seven (7) plus years of healthcare industry experience, or Associate’s degree with nine (9) years of healthcare industry experience.
Ability to communicate in regional language;
Three (3) plus years of directly related quality or regulatory experience;
Medical Device experience;
Project team environment experience;
Proven track record in people/team building skills;
Detail-oriented and well-organized;
Excellent verbal and written communication skills;
Must be motivated to work independently as well as with cross functional teams;
Solid communication skills in English;
Skill and determination to reach successful outcomes in negotiations with both inside team clients and outside parties e.g., Regulatory agencies;
Self-starter with a proactive and energetic attitude.
3 openings. Employer will assist with relocation costs.
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.