Sr. Manager - International Regulatory Affairs

| Remote
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Invitae is dedicated to bringing comprehensive genetic information into mainstream medicine to improve healthcare for billions of people. Our team is driven to make a difference for the patients we serve. We are leading the transformation of the genetics industry by making genetic testing affordable and accessible for everyone to guide health decisions across all stages of life.
 
POSITION SUMMARY:
The Sr. Manager, International Regulatory Affairs and Vigilance Reporting will be responsible for managing relationships with foreign regulatory agents and seeing international submissions for genomic devices and IVDs including companion diagnostics to a successful conclusion. For globally marketed products, this position will oversee ongoing complaint and vigilance reporting to health authorities around the world, including the USA.
 
RESPONSIBILITIES:
  • Assist with the development and implementation of regulatory procedures, particularly focused on proper documentation for medical device registration outside the USA.
  • Create draft planning documents to guide project teams on regulatory documentation requirements for a given region or country.
  • Identify and manage external partners such as authorized representatives, in-country agents, translation services, CROs and regulatory consultants.
  • Ensure Invitae's compliance to post-market requirements, such as complaint reporting, in regions where Invitae sells regulated IVD products.
  • Provide or arrange for training and informational materials to help Archer project teams with successful foreign registration.
  • Represent Invitae at regulatory meetings in-person abroad and remotely, and interact with pharmaceutical and foreign regulatory partners as needed.
  • Assist in the hosting of audits by regulatory authorities.
  • Develop and manage an international regulatory affairs team along with a high functioning post-market vigilance team which partners with other cross-functional representatives.
  • Perform other duties as assigned by supervisor, including case-by-case general compliance matters.
EXPERIENCE: 
  • Six or more years of experience in generating submissions, technical files, or other documentation in support of medical device/IVD registration outside the USA.
  • Three or more years building and supervising a successful regulatory team.
  • Strong regulatory strategic thinker with the skills to present resourcing, timeline and tradeoff scenarios to company leadership regarding global deployment of regulated products.
  • High degree of proficiency with MS Office and Adobe PDF creation.
  • Preference for candidates with language skills beyond English.
  • Familiarity medical device and/or IVD design control processes
  •  Experience with good manufacturing practice and good document practice.
  • Experience with quality systems in regulated space preferred, with responsibility for generating new documents and conducting team reviews.
  •  Fine research skills with a knack for sketching out solutions to novel issues
  • Ability to interact with multiple disciplines, and communicate clearly and effectively verbally and in writing.
  • Ability to work independently, and report progress efficiently.
  • Ability to multitask and work within a fast-paced dynamic team environment
EDUCATION:
  • Minimum B.S./B.A, preferably in a technical field.

In Colorado, our competitive compensation package includes a base salary starting from $129,000 per year.  In determining the final salary offered, we will evaluate a specific candidate's geographic location, education, skills, and experience.

Invitae offers a competitive total rewards package, which includes healthcare coverage, 401k, and a broad range of other benefits, outlined below:

  • Health, dental, vision, short- and long-term disability, and basic life insurance coverage
  • Paid time off, holiday pay, parental leave, and other health and wellness supports

At Invitae, we value diversity and provide equal employment opportunities (EEO) to all employees and applicants without regard to race, color, religion, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the San Francisco Fair Chance Ordinance.

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Technology we use

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Location

Conveniently located minutes from downtown Boulder via Pearl Street or the Goose Creek Path. Easily commutable from all directions.

An Insider's view of ArcherDX

What’s the vibe like in the office?

Collaborative - when I walk through the ArcherDX office at any time of day, I can see cross-functional collaboration in action. Our team members are constantly connecting in structured and unstructured meetings to solve problems and achieve goals.

Sarah

Corporate Recruiter

How do you collaborate with other teams in the company?

Collaboration between functional groups is key to the Logistics team's success at Archer. Working closely with Sales, Manufacturing, Assay Development, Customer Support, Finance and QA allows us to provide better customer service by improving our processes, troubleshoot, brainstorm new ideas, learn from each other and share our best "dad" jokes.

Judy

Logistics Manager

How do you empower your team to be more creative?

Creativity requires a break from the routine and the screen. Here at Archer the team gets creative through walks to the food trucks, lunch runs, climbing gym sessions or a few end of the week craft brews. Some of our best algorithms were developed or refined on the climbing gym mat.

Aaron

VP of Bioinformatics and Commercial Development

What are ArcherDX Perks + Benefits

ArcherDX Benefits Overview

ArcherDX offers a competitive and generous benefit package including:

• Medical PPO or HMO and Dental-82% of monthly premium covered by the company
• Optional vision, life, FSA, dependent care plans
• Basic AD&D, Short and Long Term disability-covered 100% by the company
• 160 hours PTO per calendar after three months of service
• 6-weeks parental leave covered 100% by the company
• 401K with company match with potential of up to $2000/year
• 2019 bonus - 5% based on company objectives (for non-commissioned employees)
• Company stock options for all employees
• Tuition Reimbursement
• Ecopass

Culture
Volunteer in local community
Partners with Nonprofits
Friends outside of work
Eat lunch together
Daily sync
Open door policy
Team owned deliverables
Team based strategic planning
Group brainstorming sessions
Diversity
Documented equal pay policy
Health Insurance & Wellness Benefits
Flexible Spending Account (FSA)
Disability Insurance
Dental Benefits
Vision Benefits
Health Insurance Benefits
Life Insurance
Wellness Programs
Retirement & Stock Options Benefits
401(K)
401(K) Matching
Company Equity
Child Care & Parental Leave Benefits
Generous Parental Leave
Remote Work Program
Our remote work program includes work from home on occasion as needed.
Family Medical Leave
Company sponsored family events
Archer sponsors family oriented events annually. This year, we had our summer picnic at the Boulder Reservoir.
Vacation & Time Off Benefits
Generous PTO
Paid Holidays
Perks & Discounts
Beer on Tap
Casual Dress
Commuter Benefits
Company Outings
Archer hosts company outings Semi-annually.
Relocation Assistance
Professional Development Benefits
Job Training & Conferences
Tuition Reimbursement
Our tuition reimbursement plan offers an annual max of $5250.
Cross functional training encouraged
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