Director Regulatory Affairs EMEA

Dexcom; United States; Remote; USD 100,000 - 125,000; Full time

Job summary

An established industry player is seeking a Director of Regulatory Affairs for EMEA to lead regulatory and quality initiatives. This pivotal role involves managing regulatory activities for medical devices across Europe and the Middle East, ensuring compliance with international regulations, and collaborating with cross-functional teams to drive market expansion. The ideal candidate will possess extensive regulatory knowledge, strong leadership skills, and the ability to navigate complex challenges in a fast-paced environment. Join a forward-thinking company dedicated to improving diabetes management through innovative technology and solutions.

Qualifications

• 15+ years of industry experience with a Bachelor's degree.
• 9+ years of successful management experience in relevant industry.

Responsibilities

• Manage regulatory affairs activities for medical device products in EMEA.
• Liaise with regulatory authorities and support compliance with regulations.
• Lead cross-functional teams to explore regulatory pathways.

Skills

Regulatory Knowledge

Leadership

Analytical Skills

Communication Skills

Problem Solving

Negotiation Skills

Multitasking

Team Building

Education

Bachelor's Degree

Job description

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 Regulatory 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:

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

Required Qualifications:

1. 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
2. Successful 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
3. Strong analytical and business skills; with the ability to communicate effectively at all levels within the organization and with regulatory agencies
4. Results-oriented, self-disciplined, fast-paced, motivated individual that requires minimal supervision and able to multitask several projects at one time
5. Highly collaborative and desire to reach across the organization to understand needs and how to meet those needs
6. Demonstrated ability to process complex information and summarize it concisely in writing and/or verbally in a professional manner
7. 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
8. Ability to organize, motivate and lead diverse engineering teams in a quickly growing and agile/flexible corporate environment
9. 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
10. 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
11. Ability to prioritize own activities and team’s to ensure spending time on the critical few priorities that are most important to the organization
12. Track record of recruiting exceptional talent, building high performing teams to include managing, mentoring and motivating employees
13. 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:

1. Experience with diabetes technologies and devices with software

Experience and Education:

1. Typically requires a Bachelor’s degree with 15+ years of industry experience
2. 9+ years of successful management experience in relevant industry

Travel Required:
• Up to 25%

#LI-REMOTE

To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications.

About the company

DexCom, Inc. is a company that develops, manufactures, and distributes continuous glucose monitoring systems for diabetes management.