20 Best senior associate director jobs in Gaithersburg, MD (Hiring Now!)

Senior Director, Head of Regulatory Science
QIAGEN —Germantown, MD
Direct the preparation and submission of high-quality regulatory filings, including premarket notifications, premarket approval applications, technical…
Quick Apply
Sr Director, Fixed Income Regulation
Finra —Washington, DC
Designs, develops and delivers fixed income guidance to staff across Regulatory Operations, as well as to member firms, including by ensuring consistency of the…
$149,600 a year
(Hybrid) Senior Director, Commercial Real Estate Administration
PenFed Credit Union —McLean, VA
Bachelor's degree in Finance, Business Administration, or related field. Monitor and manage the performance of the commercial real estate loan portfolio through…
$133,600 - $277,500 a year
Director of Congressional Relations
National Council of Urban Indian Health —Washington, DC
The Director of Congressional Relations is responsible for conducting analysis, reviewing and responding to bills, policies, preparing testimony and attending…
$100,000 - $130,000 a year
Quick Apply
Senior Program Director, Policy
Enterprise Community Partners —Maryland
The position also coordinates with Enterprise's federal policy team to align federal policy making with state, regional and local policy, and leads all…
$100,000 - $115,000 a year
Senior Director Supply Chain Management
MEDSTAR HEALTH —Washington, DC
Bachelor’s degree in business administration, supply chain management, or a similar field of study Required. Master’s degree in business administration, supply…
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Associate Director, Worship Arts
Reid Temple AME Church —Glenn Dale, MD
Formal Education in music, vocal performance, or related performance discipline (bachelor’s or master’s degree, a plus); Expected hours: 10 – 15 per week.
$50,000 - $65,000 a year
Quick Apply
4d
Senior Program Director, Impact & Evaluation
Enterprise Community Partners —Columbia, MD
Minimum of 8 years of professional experience evaluating social programs using qualitative and quantitative data collection and analysis methods (e.g., survey…
$102,000 - $110,000 a year
14d
Senior Director of Development
Mathematical Association of America —Washington, DC
Bachelor’s degree in marketing, communications, public relations or related field required. Develop and implement MAA’s strategic development plan and…
$160,000 - $170,000 a year
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Senior HR Generalist/Director
20-20 Foresight Executive Search —McLean, VA
Bachelor’s degree in Human Resources, Business Administration, or related field required; Master’s degree preferred.
$150,000 - $180,000 a year
Quick Apply
13d
Senior Advisor to the Associate Director for Innovation and Industry Services
US National Institute of Standards and Technology —Gaithersburg, MD
Demonstrated experience in communicating and effectively collaborating with a diverse set of customers and stakeholders, such as senior-level federal officials,…
$147,649 - $221,900 a year
Sr Resident Care Director RN
Sunrise Senior Living —McLean, VA
Maintains current state license as a Professional Registered Nurse per state regulations in the states they cover and support.
Estimated: $92.8K - $117K a year
Associate Director, Commercial Finance
Greenhouse Agency —United States
Strategic Visionary: You have a knack for seeing the big picture and driving strategic initiatives that move the needle.
$130,000 - $150,000 a year
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Senior Float Director of Nursing
Sunrise Senior Living —McLean, VA
Maintains current state license as a Professional Registered Nurse per state regulations in the states they cover and support.
Estimated: $94.7K - $120K a year
Associate Director of Validation Consultant
The Verity Collective —Rockville, MD
Review current risk scenarios and advise on additional risks. Oversight of CSV activities for Document Control and Training Systems (should be able to provide…
$80 - $120 an hour
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11d
Associate Director, Facilities
Regenxbio —Rockville, MD
Facilities Management certifications (FMP, CFM) and/or Procurement certification - CPM, APICS, MCIPS certification or equivalent preferred.
Estimated: $109K - $138K a year
Quick Apply
3d
Associate Program Director, Alumni Events & Programs
University of Maryland —College Park, MD
A valid driver’s license and access to a vehicle are required for this position. They will provide full event lifecycle management, including setting objectives…
$85,000 - $100,000 a year
12d
Associate Director Office of Health Services
US Peace Corps —Washington, DC
MINIMUM EDUCATION REQUIREMENT(S), GS-0601: Education: Bachelor's or graduate/higher level degree: major study in an academic field related to the medical field,…
$147,649 - $204,000 a year
3d
Associate Director, Supply Chain Operations
Arcellx —Rockville, MD
Your work will allow us to advance seamlessly and successfully towards getting our transformative cell therapies through clinical trials and to patients who…
Estimated: $162K - $205K a year
Quick Apply
12d
Senior Director Programs
Leonardo DRS —Germantown, MD
This role will also involve providing strategic direction, managing program cost, schedule, and performance objectives, and driving continuous improvement…
Estimated: $170K - $215K a year

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Senior Director, Head of Regulatory Science

QIAGEN - Germantown, MD

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Job Details

Full-time

Benefits

Stock options
Health savings account
Employee stock purchase plan
Health insurance
Dental insurance
401(k)
Paid time off
Vision insurance
401(k) matching
Life insurance
Referral program
Retirement plan

Qualifications

Management
Leadership
Communication skills
ISO 13485
FDA regulations
10 years

Full Job Description

Overview

At the heart of QIAGEN’s business is a vision to make improvements in life possible.

We are on an exciting mission to make a real difference in science and healthcare. We are still the entrepreneurial company we started out as and have today achieved a size where we can bring our full power to many initiatives and to our presence across the globe.
Our most valuable asset are our employees – more than 6000 in over 35 locations around the world. Our ambition is to ensure we have outstanding and passionate people working in the best teams and we are constantly looking for new talent to join us.
There are few players who have shaped the world of modern science and healthcare as much as QIAGEN, and we have only just started.
If you are looking to advance your career, are seeking new challenges and opportunities, enjoy working in dynamic and international, diverse teams and want to make a real impact on people’s lives, then QIAGEN is where you need to be.

Join us. At QIAGEN, you make a difference every day.

Position Description

The Senior Director, Head of Regulatory Science will report to the VP, Head of Global Regulatory Affairs and will lead a global team of highly experienced regulatory professionals with business-focused regulatory affairs responsibility. The position will be responsible for the support and continuous improvement of QIAGEN’s Regulatory Science and intelligence functions helping to make improvements in life possible.

The Senior Director, Head of Regulatory Science will provide leadership to the QIAGEN Global Regulatory Science Team with a focus on driving analysis, influencing, and the adoption of new/changing regulations & standards. They lead and inspire the team to develop and deliver on competitive and innovative regulatory strategies and regulatory milestones, including an assessment of risks and mitigations, emerging data, and the probability of success of individual submissions.

The position will also serve as a strategic partner to QIAGEN business leaders and enable goal achievement by providing valuable insights and creative regulatory affairs solutions.

The position is to be based in QIAGEN America Headquarters in Germantown, Maryland.

Primary Responsibilities

- Collaborate with cross-functional teams, including R&D, Quality Assurance, Clinical and Medical Affairs, and Marketing, to ensure regulatory requirements and strategy are considered in product development, including verification and validation activities, risk management, and throughout the product lifecycle.

- Direct the preparation and submission of high-quality regulatory filings, including premarket notifications, premarket approval applications, technical documentation summaries, and medical device license applications, to the US FDA, EU Notified Bodies, and Health Canada, and provide support for other global regulatory filings.

- Interact and negotiate with regulatory agencies during regulatory submissions, audits/ inspections, and other interactions to ensure successful outcomes.

- Provide strategic regulatory advice and manage internal processes to ensure effective communication across QIAGEN Business Areas regarding relevant policy, new or changing regulations, standards and standards related intelligence, trends, and changes.

- Support and evolve processes for regulatory intelligence to monitor and analyze regulatory changes, assessing the impact on the company's products and projects, and communicating relevant updates to internal stakeholders.

- Establish and maintain relationships with key regulatory authorities and participate in industry associations to stay informed about the evolving regulatory landscape and industry trends.

- Support other QIAGEN functions in partner and customer facing issues involving Regulatory Affairs aspects.

- Drive continuous improvement and consistency of regulatory science processes and guidance across business areas served.

- Lead and manage a team of regulatory professionals, providing guidance, coaching, and mentorship to foster their professional development and ensure business and departmental objectives are met.

- Strong leadership and management skills, with experience leading and developing high-performing teams

Position Requirements

- The ideal candidate will have a minimum 10 years of experience in regulatory affairs, with at least 5 years in a leadership role, for in vitro diagnostic (IVD) companies.

- A degree in a scientific or engineering discipline is desirable.

- Deep knowledge of regulatory requirements for IVD products, including FDA regulations (e.g., 510(k), PMA), EU IVDR, and other relevant international regulations.

- Strategic experience and ability, having demonstrated success related to the development and implementation of regulatory strategies for IVD products, ensuring compliance to all applicable regulations.

- Success in problem solving and developing risk-based solutions, with the capacity to navigate complex regulatory landscapes.

- Proven track record for successful regulatory submissions and clearances/approvals for IVD products; experience with companion diagnostics is a plus.

- Understanding of global regulatory, government affairs, and legal liability issues, FDA QSR, and ISO 13485 required.

- Demonstrated experience and acumen in interfacing with and working with regulatory agencies, including FDA.

Personal Requirements

- Excellent verbal and written communications skills and the ability to convey complex regulatory requirements in a straightforward and practical manner across all levels within QIAGEN.

- Ability to work well cross-functionally, and in team settings and independently, take a stand and ensure completion of time-critical projects.

- Strategic thinker, with ability to find novel solutions to complex regulatory and business challenges.

- Structured and well organized.

- Confident with excellent cross-functional influencing skills.

- Good business acumen, pragmatic and business oriented.

- Able to identify and focus on the key priorities.

- Self-starting, self-reliant, courage of conviction.

- Passionate leader, enthusiastic and able to inspire others to drive results while helping team members feel competent, challenged, and supported.

- Strong communicator and influencer who is able to foster a trusted and collaborative relationship between Regulatory Affairs team and the business through diplomatic communication style.

- Unimpeachable ethics and a commitment to uncompromising integrity, known as a QIAGEN culture carrier.

- Passionate in driving Diversity and Inclusion.

QIAGEN requires proof of full COVID-19 vaccination as a condition of employment for new hires in all U.S. states other than Montana effective as of September 1, 2021. New hires and candidates will be required to present proof of full COVID-19 vaccination within three business days of start date or upon entry into the office (i.e., for interviews), whichever comes first. QIAGEN complies with applicable laws regarding the confidentiality of employee health information and the reasonable accommodation of individuals with disabilities and/or sincerely held religious beliefs. Candidates who require accommodation should contact Benefits@QIAGEN.com. This policy is part of QIAGEN’s ongoing efforts to support public health efforts and to ensure the safety and-well-being of its employees, customers, business partners, and community.

What we offer

At the heart of QIAGEN are our people who drive our success. We act with passion, always challenging the status quo to drive innovation and continuous improvement. We inspire with our leadership and make an impact with our actions. We create a collaborative, safe and engaging workplace which forms the basis for high performing individuals and teams. We drive accountability and entrepreneurial decision-making and want you to excel your growth and shape the future of QIAGEN.

QIAGEN is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, and medical conditions related to pregnancy, childbirth, or breastfeeding), sex stereotyping (including but not limited to assumptions about a person’s appearance or behavior, gender roles, gender expression, or gender identity), gender, gender identity, gender expression, national origin, age, mental or physical disability, ancestry, medical condition, marital status, military or veteran status, citizenship status, sexual orientation, genetic information, or any other status protected by applicable law.

Job Type: Full-time

Benefits:

401(k)
401(k) matching
Dental insurance
Health insurance
Health savings account
Life insurance
Paid time off
Referral program
Retirement plan
Vision insurance

Compensation package:

Bonus opportunities
Employee stock purchase plan
Performance bonus
Stock options
Yearly pay

Experience level:

10 years

Schedule:

Monday to Friday

Work Location: Hybrid remote in Germantown, MD 20874

Quick Apply

senior associate director jobs in Gaithersburg, MD

Senior Director, Head of Regulatory Science

Sr Director, Fixed Income Regulation

(Hybrid) Senior Director, Commercial Real Estate Administration

Director of Congressional Relations

Senior Program Director, Policy

Senior Director Supply Chain Management

Associate Director, Worship Arts

Senior Program Director, Impact & Evaluation

Senior Director of Development

Senior HR Generalist/Director

Senior Advisor to the Associate Director for Innovation and Industry Services

Sr Resident Care Director RN

Associate Director, Commercial Finance

Senior Float Director of Nursing

Associate Director of Validation Consultant

Associate Director, Facilities

Associate Program Director, Alumni Events & Programs

Associate Director Office of Health Services

Associate Director, Supply Chain Operations

Senior Director Programs

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