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.
Director Regulatory Strategy Software Devices NPD-AI/Machine Learning
YOUR TASKS AND RESPONSIBILITIES
The primary responsibilities of this role, Director Regulatory Strategy Devices NPD Digital, are to:
- Develop and implement global Regulatory strategies for key new product development digital projects, ensure that pre-market digital regulatory requirements are captured in global regulatory strategies and development plans, while balancing business objectives;
- Develop and implement regional/local Regulatory project goals for key digital projects;
- Lead and/or participate on key NPD Regulatory Affairs Teams and/or Global Project Teams;
- Lead preparations and conduct/follow-up for top priority project meetings and teleconferences with U.S./Can/EU HA officials and aid in other country HA meeting preparation/conduct/follow-up;
- Be responsible for the preparation of key 510(k) and international submissions for digital projects as well as preparation and maintenance of E.U. technical files to ensure European Medical Device Regulations compliance;
- Ensure digital submissions and technical documentation are consistent with the business strategy;
- 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 for digital projects;
- Clearly communicate recommended digital strategies and changing local digital regulatory requirements, including necessary adaptions to peers, senior management and cross-functional teams;
- Ensure digital device compliance, including change management and ad/promo review, 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 identify regulatory issues/risks and leads/executes mitigation plans;
- Act as a company liaison to industry trade associations for digital topics;
- Review and suggest possible organization reaction to new or proposed digital legislation;
- Provide Regulatory support and cross-functional activity for key digital device product recalls and risk management documentation;
- May work on assigned special projects such as contributing to Regulatory Affairs functional improvement initiatives;
- Be capable of performing these tasks with little to no 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:
- Bachelor's degree with at least nine years of Regulatory device experience; OR a Master's degree with at least seven years of Regulatory device experience; OR a Ph.D., M.D., P.Eng.; OR a PharmD with at least five years of Regulatory device experience;
- Proven experience and demonstrated innovation working with digital medical device regulations;
- Strong knowledge of Quality System Regulations;
- Proven experience filing and gaining clearance for FDA 510(k) digital submissions;
- Familiarity and positive interactions with key Health Authorities;
- Ability to articulate and solve complex regulatory device issues independently;
- Strong ability to communicate and negotiate effectively in English both verbally and in writing;
- Experience in managing cross-functional teams and mentoring more junior employees;
- Strategy and results orientation;
- Ability to experiment;
- Business acumen and commercial orientation;
- Ability to collaborate;
- Proficiency in English language.
- Experience providing Regulatory support for digital medical devices utilizing artificial intelligence or machine learning.
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. 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.
State: Residence Based
Location: Residence Based
Reference Code: 261001
Functional Area: Regulatory Affairs
Entry Level : Professional