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.

Head Global Regulatory Strategy, Devices New Product Development

Your tasks and responsibilities

The primary responsibilities of this role, Head Global Regulatory Strategy, Devices New Product Development, are to: 

 

  • Provides guidance and oversight to Global Regulatory Strategists NPD Team with regard to the development and implementation of global Regulatory strategies ensuring that key regional and local Regulatory requirements are captured in global regulatory strategies and development plans;
  • Oversees and supervises the development and implementation of regional/local Regulatory project goals from development through life- cycle;
  • Supervises and manages all Global Regulatory Strategists Device NPD. Represents Global Regulatory Affairs on directly assigned global Project Teams;
  • Actively involved in decision making on all key development and line extension questions as part of the product development process;
  • Supervises and drives preparations for meetings and teleconferences with local and global HA officials/Technical Bodies;
  • Responsible for training of the Global Regulatory Strategists NPD and the oversight and review of 510(k) and International submissions as well as technical documentation in compliance with the European Medical Device Regulations;
  • Ensure submissions and technical documentation are consistent with the business strategy. For directly assigned projects, develops regional/local submission/technical documentation materials, guides the review process, checks for accuracy, technical consistency, compliance to local and global HA regulations and completeness of submission;
  • Advises Global Regulatory management and/or other functional areas of regulatory trends and their relevance to NPD projects. Keeps abreast of new or revised regulations, and analyzes and assesses impact on company and product development initiatives; educates team members on new regulations and anticipates necessary adaptations;
  • Oversees project compliance, including change management and LMR review, with all applicable regulations and standards and proactively monitors the competitive landscape and advises organization on actions to be taken with regard to opportunities or threats;
  • Oversees/Leads Regulatory support and cross-functional activity (as necessary) for all device product recalls and risk management documentation.
     

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:

 

Required Qualifications:

 

  • Ph.D., M.D., P.Eng. or PharmD with a minimum of 6 years of Regulatory device experience; or Master's with a minimum of 8 years of Regulatory device experience; or a Bachelor's degree with a minimum of 12-15 years of Regulatory device experience;
  • Proven Regulatory experience and track-record in the device industry;
  • Strong working knowledge of Quality System Regulations, Medical Device Regulations, international regulations, FDA guidance, and international standards;
  • Expertise in FDA and EU medical device 510(k)/technical documentation requirements;
  • Demonstrated successful interactions with local and global Health Authorities;
  • Demonstrated ability to articulate and solve complex regulatory device issues;
  • Proven ability to communicate and negotiate effectively in English both verbally and in writing;
  • Proven history of leadership, motivational and interpersonal skills;
  • Successful track-record in contributing to/managing cross- functional teams;
  • The successful candidate will display: Strong sense of curiosity; Proven business acumen and commercial orientation; Drive for results; Ability to experiment

 

Your application

Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.

Bayer is an Equal Opportunity Employer/Disabled/Veterans

 

Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.

 

Country: United States
Location: NJ-Whippany, PA-Indianola
Functional Area: [sap_fa_32]
Entry Level: 5