Senior Manager, Regulatory Affairs (Medical Devices) - 6 Month Contract
Innomar Strategies
Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!
Job Details
Primary Duties and Responsibilities:
- Build and maintain a positive and productive liaison with internal and external contacts, serving as key point of contact with clients/agency contacts, as assigned.
- Participate in professional activities such as offering industry training, conference presentations, publications and webinars as assigned
- Maintenance of target billables
- Develop simple client proposals; engage in activities to generate new business for TPIreg as assigned, including participation in presentations to potential clients
- Follows Innomar and client best practices and SOPs to ensure quality control of documents; seeks to identify opportunities for process improvement
- Analyzes data, the regulatory environment and business objectives to make recommendations, using judgement to seek innovative solutions.
- Develops and maintains partnerships with peers in other departments to formulate strategies and help achieve business results
- Manage and lead agency interactions, with support as needed
- Prioritize and manage assigned projects to meet budget (including invoice review), timelines and client expectations; identify and propose solutions to emerging issues
- Engage in continuous learning in order to provide effective consulting services and train/coach colleagues.
- Manages decision-making and conflict resolution surrounding regulatory issues for assigned projects
- Identifies and shares regulatory intelligence
- Other related duties as assigned
Minimum Skills, Knowledge and Ability Requirements:
- Demonstrated project management skills to manage multiple concurrent projects within established timelines in a dynamic environment.
- Advanced strategic planning and problem-solving skills to resolve issues effectively and efficiently.
- Demonstrated leadership abilities in a cross-functional, multi-disciplinary team environment.
- Direct experience and working knowledge of a wide range of regulatory submission types and medical device types
- Technical expertise across the medical device life cycle.
- Strong working knowledge of local Health Authority regulations, guidelines and policies. Includes working knowledge of IMDRF, ICH, Health Canada, FDA, EMA, and other relevant requirements.
- Experience of successfully managing Health Authorities interactions on a regional basis
- Ability to develop professional networks that will support business development and regulatory intelligence
- Strong business and financial acumen
- Strong analytical and mathematical skills
- Ability to communicate effectively both orally and in writing
- Strong interpersonal skills
- Strong leadership skills
- Effective organizational skills; attention to detail
- Ability to consistently meet deadlines
- Excellent problem-solving skills; ability to resolve issues effectively and efficiently
- Demonstrated presentation skills
- Knowledge of computers to operate effectively with Adobe Acrobat, Microsoft Word, Excel, Microsoft Outlook
What Cencora offers
We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members’ ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more.
Full timeEqual Employment Opportunity
Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.
The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.
Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email hrsc@cencora.com. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned
Accessibility Policy
Cencora is committed to fair and accessible employment practices. When requested, Cencora will accommodate people with disabilities during the recruitment, assessment and hiring processes and during employment.