Senior Specialist

Completes and maintains regulatory approvals and clearances of assigned products.

**Key Responsibilities**:

- Create complex regulatory submissions/playbook, exercising judgment to protect proprietary information for finalization and submission by EW France affiliate ; track timelines and document milestone achievements, develop regulatory strategy, prioritize regulatory activities with operating plans as well as ensuring alignment in countries/area of work (e.g., country cluster, COE )
- Identify and develop complex Regulatory Affairs process improvement initiatives including system enhancements, training, reports and/or dashboards including proposing alternative solutions and recommendations. Execute all RA activities in Edwards systems to ensure compliant product distribution, interacting with regulatory authorities on informative level
- Lead portions of projects to identify trends, assess impact, analyze alternatives and recommend action plans
- Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives and resolving conflicts between those requirements and development issues, and/or reporting to management.
- Prepare documents for submissions, including assuring the appropriate forms for all appropriate regulatory bodies
- Provide guidance and feedback to stakeholders on regulatory activities (e.g., strategies, contingency plans, registration requirement) including assessing impact of regulations and proposing suggestions.
- Review and approve materials (e.g., collateral) from cross-functional teams
- Requests for clinical trial authorizations in the relevant location and monitoring their progress, report serious adverse events
- Local implementation of corrective actions
- Tasks linked to the first marketing of a new medical device (communication, distribution licences...).
- Provide training and knowledge transfer to team members
- Other incidental duties assigned by Leadership

**Education and Experience**:
Bachelor's Degree in in related field, 5 Years years experience previous related experience Required
in scientific discipline (e.g., Biology, microbiology, Chemistry) Preferred

**Other**: Coursework, seminars, and/or other formal government and/or trade association training Required
Experience in preparing domestic and international product submissions Preferred

**Additional Skills**:

- Good medical writing skills
- Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel
- Good problem-solving, decision-making, organizational, analytical and critical thinking skills
- Excellent written and verbal communication skills including negotiating and relationship management skills
- Ability to read, write and speak English and French required;
- Strong knowledge and understanding of global regulations relevant to medical devices, Class I, II and/or Class III devices (Medical Devices Regulation) as well as the French regulatory requirements.
- Full knowledge and understanding of global regulatory requirements for new products or product changes.
- Full knowledge of new product development systems
- Strict attention to detail
- Good leadership skills and ability to influence change
- Ability to interact professionally with all organizational levels
- Ability to manage competing priorities in a fast paced environment
- Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
- Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
- Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

What is it like to work at Edwards Lifesciences in France?

As a global leader in patient-focused medical innovations, we offer rewarding opportunities and exciting challenges in a truly international, dynamic and friendly work environment.

We are committed to fostering a diverse and inclusive work environment where all employees can grow, personally and professionally.

To achieve this, we offer on-the-job development, training opportunities and the support and guidance provided by dedicated employee groups (the Edwards Network of Women, Edwards Foundation charity team, sustainability activities, and others).

Edwards Lifesciences in France also offers the following benefits:
Competitive Compensation and Benefits package
Flexible working hours, remote working
Profit sharing
Risk Life Insurance
Comprehensive Medical plan (including online access to healthcare)
Service Awards
Works Council social and cultural activities
Enhanced Leave Benefits
Employee Stock Purchase Program
Emplo