Senior Regulatory Affairs Specialist

| Greater Boulder Area
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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 Senior Regulatory Affairs Specialist will help develop and prepare global regulatory submissions for new products and product changes, implement and maintain regulatory processes within the Quality Management System (QMS), and work with cross functional teams to mitigate or resolve regulatory issues and support responses to questions from regulatory agencies. 


RESPONSIBILITIES:

  • Develop and implement or revise regulatory procedures to reflect regulatory requirements 
  • Participate in communication with regulatory agencies
  • Create and manage filings for IDE, 510(k), PMA and EU Technical Files.
  • Own and drive assignments from project core teams to completion and support other initiatives on a departmental basis.
  • Evaluate customer complaints to determine if regulatory notification is required.
  • Support and/or own regulatory compliance activities, including review or creation of documentation supporting the manufacture of companion diagnostics, GMP audits, post market reporting, etc.  
  • Perform other duties as assigned by supervisor

EXPERIENCE

  • 3+ years of medical device regulatory affairs experience, prefer proven experience as a primary submission owner
  • High degree of proficiency with MS Office and Adobe PDF creation
  • Familiarity with regulatory submissions including IDE, 510(k), and PMA for IVD and/or Companion Diagnostics
  • 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.
  • Ability to interact with multiple disciplines, and communicate clearly and effectively verbally and in writing.
  • Ability to work independently, and utilize good problem-solving skills
  • Ability to multitask and work within a fast-paced dynamic team environment

KEY ATTRIBUTES:

  • Must be hands-on, self-directed, organized and conscientious;
  • Demonstrated hands on change management leadership skills;
  • Excellent written and verbal communication skills;
  • Problem solving prowess in consistently evolving environment;
  • Proven ability to work under pressure and with short deadlines to accomplish objectives;
  • Ability to communicate effectively with technical and non-technical personnel.

EDUCATION:

  • Bachelor’s degree required;
  • Graduate degree in molecular biology, engineering and/or relevant scientific discipline highly desired;
  • Knowledge of manufacturing in a regulated environment (ISO 13485, 21CFR820, cGMP) and related manufacturing and process control requirements.

In Colorado, our competitive compensation package includes a base salary starting from $100,000.  In determining the final salary offered, we will evaluate a specific candidate's geographic location, education, skills, and experience.

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 Invitae (Formerly ArcherDx)

What’s the vibe like in the office?

Collaborative - when I walk through the Invitae 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 Invitae. 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 Invitae (Formerly ArcherDx) Perks + Benefits

Invitae (Formerly ArcherDx) Benefits Overview

At Invitae, our employees are the key to our continued success. Our culture is one of our most important strengths. A set of commitments we make to each other and to our customers to build a world-class organization in service of our mission. That is why Invitae proudly offers comprehensive perks and benefits program with choice and flexibility in mind.

Culture
Volunteer in local community
Friends outside of work
Eat lunch together
Intracompany committees
Daily sync
Open door policy
Team owned deliverables
Team based strategic planning
Group brainstorming sessions
Open office floor plan
Diversity
Dedicated Diversity/Inclusion Staff
Highly diverse management team
Unconscious bias training
Diversity manifesto
Someone's primary function is managing the company’s diversity and inclusion initiatives
Mean gender pay gap below 10%
Diversity Employee Resource Groups
Hiring Practices that Promote Diversity
Health Insurance & Wellness Benefits
Flexible Spending Account (FSA)
Disability Insurance
Dental Benefits
Vision Benefits
Health Insurance Benefits
Life Insurance
Pet Insurance
Wellness Programs
Team workouts
Mental Health Benefits
Retirement & Stock Options Benefits
401(K)
401(K) Matching
Company Equity
Employee Stock Purchase Plan
Performance Bonus
Child Care & Parental Leave Benefits
Generous Parental Leave
Flexible Work Schedule
Remote Work Program
Our remote work program includes work from home on occasion as needed.
Family Medical Leave
Restricted work hours
Return-to-work program post parental leave
Vacation & Time Off Benefits
Unlimited Vacation Policy
Generous PTO
Paid Holidays
Paid Sick Days
Perks & Discounts
Beer on Tap
Casual Dress
Commuter Benefits
Company Outings
Archer hosts company outings Semi-annually.
Happy Hours
Relocation Assistance
Professional Development Benefits
Job Training & Conferences
Tuition Reimbursement
Our tuition reimbursement plan offers an annual max of $5250.
Diversity Program
Lunch and learns
Cross functional training encouraged
Promote from within
Mentorship program
Time allotted for learning
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