Director Regulatory Affairs Emea

**About Dexcom**

Founded in 1999, Dexcom, Inc. provides continuous glucose monitoring technology to help patients and their clinicians better manage diabetes. Since our inception, we have focused on better outcomes for patients, caregivers, and clinicians by delivering solutions for people with diabetes - while empowering our community to take control of diabetes.

Dexcom is recruiting a

**Director Regulatory Affairs for EMEA**

to represent Regualtory and Quality matters as a member of the EMEA Leadership Team. This includes collaborating and providing guidance on associated matters and providing leadership for global and regional regulatory and quality approved processes.

**Essential Duties and Responsibilities**:

- Serve as EMEA extension of the Corporate Regulatory Affairs Team
- Direct, manage and organize Dexcom’s European and Middle Eastern regulatory affairs activities for certain current and future medical device products
- Support, control, and manage EMEA Distributors to comply with regulatory requirements with regulations and quality agreements
- Act as liaison international regulatory authorities for assigned products
- Define the strategy for preparing US and OUS device submissions and prepare submissions as required
- Maintain knowledge on changing worldwide regulations and standards that are germane to Dexcom’s business
- Liase with commercial teams in supporting tender and other other commercial contractual agreement requirements. Communicate new regional requirements to regulatory affairs and quality
- Work with EMEA commercial and corporate regulatory and quality teams for global market expansion activities
- Work through cross-functional teams, explore regulatory pathways, assess and communicate key activities and associated risks
- Serve as EMEA extension of Corp Quality Systems & Compliance Team
- Point person and internal liaison for quality systems, registrations, renewals, certifications and post-market quality related needs, risks, business strategy and communications
- Fulfil responsibilities of Importer under MDR Article 13
- Support FSCA execution
- Raise awareness of post-market compliance escalations with EMEA Leadership Team
- Relationship building - component authority and economic operators
- Serve as EMEA extension of Quality Assurance Team
- Local support for competent authority 'Additional Information Requests' (support Customer Advocacy) - raise awareness on current trends with EMEA Leadership Team
- Serve as liaison with EMEA leadership team on key post-market product escalations and investigations

**Required Qualifications**:

- Demonstrated knowledge of EU, Middle East and other applicable international regulatory requirements including clinical trial requirements, quality system requirements, submission requirements, labeling and promotion requirements
- Succcessful track record working in a matrix environment and demonstrated leadership with direct and indirect reporting relationships, to include the ability to effectively influence without direct authority
- Strong analytical and business skills; with the ability to communicate effectively at all levels within the organization and with regulatory agencies
- Results-oriented, self-disciplined, fast-paced, motivated individual that requires mínimal supervision and able to multitask several projects at one time
- Highly collaborative and desire to reach across the organization to understand needs and how to meet those needs
- Demonstrated ability to process complex information and summarize it concisely in writing and/or verbally in a professional manner
- Proven ability to effectively negotiate and influence both internal and external groups in a direct and diplomatic way while able to hold ground without damaging relationships and minimizing noise
- Results-oriented, self-disciplined, fast-paced, and motivated individual
- Ability to organize, motivate and lead diverse engineering teams in a quickly growing and agile/flexible corporate environment
- Ability to deal with ambiguity - ready and able to effectively and efficiently change plans quickly to meet the changing needs of the business and projects
- Proven ability solving complex problems, with the ability to get to true problem that needs to be solved and foresee problems and proactively mitigate before they happen
- Ability to prioritize own activities and team’s to ensure spending time on the critical few priorities that are most important to the organization
- Track record of recruiting exceptional talent, building high performing teams to include managing, mentoring and motivating employees
- Strong Communication (oral/written) including strong presentation skills and ability to communicate in small and large settings and at all levels in the organization, including senior level management

**Preferred Qualifications**:

- Experience with diabetes technologies and devices with software

**Experience and Education**:

- Typically requires a Bac