Senior Director, Regulatory Affairs, Advertising & Promotion
Company: Patelco Credit Union
Posted on: February 15, 2021
Senior Director, Regulatory Affairs, Advertising & Promotion
Friday, February 5, 2021 As a leading provider of innovative
technologies for the treatment of Atrial Fibrillation (Afib) and
related conditions, electrophysiologists and cardiothoracic
surgeons around the globe count on AtriCure to deliver
best-in-class solutions that can treat even the most complex cases.
Our Isolator-- Synergy--- Ablation System is the first and only
medical device approved by the FDA for the treatment of long
standing persistent Afib, our AtriClip Left Atrial Appendage (LAA)
Exclusion System products are the most widely used LAA management
devices worldwide, and we are expanding into pain management
therapies. We invest in innovation, clinical science, and education
to focus on improving lives for our patients' worldwide. POSITION
SUMMARY: This position will responsible for leading AtriCure's
advertising and promotion materials review process to ensure
compliance with product registrations and regulatory requirements
worldwide throughout the product life cycle.The Sr. Director will
work collaboratively with Marketing, Scientific Affairs, Health
Economics and Reimbursement, Legal/Compliance, Sales and
International Distributors to develop and implement advertising and
promotional labeling for AtriCure's product portfolio, applying (i)
insight and sound judgment to make solid decisions on promotional
programs, and (ii) expertise and organizational influence to
develop promotional programs and tactics that align with applicable
laws, regulations, and company policies, all while supporting the
achievement of business objectives. ESSENTIAL FUNCTIONS OF THE
- Execute on advertisement/promotional policies and procedures
for Commercial Materials distributed both internally within
AtriCure as well as globally to external customers.
- Ensure communications are truthful, non-misleading, accurate,
and fairly balanced as well as supported by reliable, sound
scientific data on file.
- Maintain a deep and current awareness of evolving FDA, European
and International regulations and interpretations, advisory
comments, enforcement actions and policy issues affecting the
medical device Industry.
- Identify, interpret and communicate regulatory perspective on
advertising and promotional activities and related risk to relevant
stakeholders and management.
- Partner with Marketing, Scientific Affairs, Health Economics
and Reimbursement, Legal/Compliance, Sales, International
Distributors and other departments as needed to ensure Commercial
Materials are reviewed in a timely, consistent manner across
AtriCure platform of products throughout the product
- Ensure commercial communications and promotional claims are
consistent and appropriate in view of product registrations,
applicable laws, regulations, and policies and supporting by
sufficient substantiating evidence on file.
- Assess advertising and promotion-related processes and
procedures to enhance efficiencies and recommend/implement policy
and/or process changes as needed.
- Monitor company website content for accuracy in accordance with
an established review schedule.
- Surveil competitor advertising to keep abreast of market
promotional and advertising strategies and identify potentially
violative competitive materials.
- Interface with relevant regulatory authorities and notified
bodies as needed.
- Maintain associated advertising/promotion best practices
documents, tools, procedures, and work instructions.
- Own and maintain claims matrices for products for agency review
and claims traceability.
- Train employees to CMR (Commercial Material Review) policies
during employee on-boarding and annual updates. ADDITIONAL
ESSENTIAL FUNCTIONS OF THE POSITION:
- Regular and predictable work performance
- Ability to work under fast-paced conditions
- Ability to make decisions and use good judgment
- Ability to prioritize various duties and multitask as
- Ability to successfully work with others
- Additional duties as assigned BASIC QUALIFICATIONS:
- Bachelor's degree required or demonstrated equivalent
combination of education, training and experience
- 8 years of regulatory affairs experience in a medical device
manufacturing environment, with experience executing and/or
managing functional areas described above
- Extensive knowledge of global medical device regulations and
standards particularly related to labeling and promotion including
but not limited to FDA, EU and International Requirements.
- Demonstrated leadership with the ability to proactively
identify and communicate risks and opportunities and the ability to
effectively influence and implement change.
- Ability to work in a fast-paced, technically challenging
environment where drive is critical to success
- Effective interpersonal and communication skills, diplomacy and
ability to influence across business functions
- Proficient computer skills; able to use standardized office
software products, i.e., Microsoft Word, Excel, PowerPoint,
- Ability to travel 25% PREFERRED QUALIFICATIONS:
- Regulatory Affairs Certification (RAC)
- Previous experience with ablation, cardiac surgery and Left
Atrial Appendage (LAA) closure devices OTHER REQUIREMENTS:
- Ability to regularly walk, sit, or stand as needed
- Ability to occasionally bend and push/pull as needed
- Ability to pass pre-employment drug screen and background check
AtriCure has a variety of benefits available for US based employees
and their families. Examples include Medical & Dental beginning day
1 of employment, 401K plus match, 15 days of paid Parental Leave,
in addition to maternity leave, for new moms and dads, Volunteer
Time off, PetInsurance, and more. Corporate-based employees also
have full access to our on-site fitness center and cafeteria. To
see a complete list of our benefits, please visit our careers
website: https://www.atricure.com/benefits AtriCure participates in
the federal E-Verify program to confirm the identity of and
employmentauthorization of all newly hired employees. For further
information about the E-Verify program, please click here
https://www.e-verify.gov/ AtriCure is an Equal Employment
Opportunity/Affirmative Action employer and provides Drug Free
Workplaces. All qualified applicants will receive consideration for
employment without regard to race, color, religion, sex, national
or ethnic origin, age, protected veteran status, status as an
individual with disability, sexual orientation, gender identity or
any other characteristic protected by federal, state, or local
Keywords: Patelco Credit Union, Minnetonka , Senior Director, Regulatory Affairs, Advertising & Promotion, Executive , Minnetonka, Minnesota
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