Regulatory Manager- IVD/Medical Devices - Ion Torrent
Life Technologies is seeking an experienced Regulatory Manager to strategically support U.S. and International In-Vitro Diagnostic Medical Device regulatory activities at its Carlsbad, California or South San Francisco facilities (Ion Torrent). The incumbent will work in the Global Regulatory Affairs department to establish and execute the regulatory strategy and submissions related to Ion Torrent products including Next Generation Sequencing technologies. In addition, incumbent will maintain appropriate systems to ensure Regulatory Compliance consistent with state, federal and international laws. Candidates with extensive knowledge and experience in the IVD industry are encouraged to apply as the positions title and responsibilities may expand in the future.
Position Objective Overview :
Provides Regulatory Affairs and Regulatory Compliance support to Life Technologies South San Francisco site. Main activities surround developing product regulatory strategies, guiding project teams through the “regulatory terrain”, and determining submission requirements. The review of advertising and promotional materials for both RUO and IVD products and the delivery of regulatory guidance to the business/ project team; are key activities toward assisting the Company in achieving its business goals.
Incumbent will serve as a member of the Global Regulatory team and will have direct line reporting to: Sr. Manager, Regulatory Affairs.
Essential Functions :
As one of the sites regulatory experts, the incumbent is required to provide guidance to assure that all regulatory submissions and compliance matters are planned, communicated and executed per regulatory and business requirements. In addition, this position serves as a subject matter expert on various regulations and coordinates regulatory issue resolution through the use of internal resources, regulatory agencies, and outside consultants as needed. Requires the ability to provide solutions based on their own knowledge and industry experience base. Detailed activities include:
· Provide active and ongoing regulatory guidance to site and project teams
· Document regulatory strategies for product submissions.
· Review advertising and promotional materials for both RUO and IVD products.
· Prepare U.S. 510(k) regulatory submissions for Next Generation Sequencing platforms
· Prepare/ maintain Technical Files for European CE-IVD products as well as other regional authorities
· Prepare/ maintain state and federal medical device establishment registration and listings.
· Obtain regulatory permits, including import / export
· Regulatory assessment of new and changed products.
· Keep abreast of new or revised regulations, guidelines, points to consider, compliance guides, inspection reports, journals, meetings, etc.
· Conduct trainings and/or communicate appropriate materials, as needed, in order to enhance site/ team’s knowledge of working in a regulated environment.
· Assist Regulatory department in the update, enhancement, and creation of internal policies and procedures.
· May perform audits, both physical and paper, to ensure compliance with various regulations.
· May coordinate audit(s) through outside vendor. Some travel may be required.
Educational Requirements :
A minimum B.Sc. degree in Biology, Chemistry, bio-engineering or related science.
Experience Requirements :
Must have a minimum of 5 years of IVD Regulatory Affairs experience. This experience must include either 510(k) or PMA Submissions. Experience with CE-IVD Technical Files (IVDD) is a plus. Must be well versed in the aspects of design control, cGMP/Quality Systems, and import/export requirements. Experience with RUO products.
Experience as the RA representative on project core teams providing active and successful regulatory guidance and RA strategies.
Experience in balancing regulatory requirements and applying them from a compliance perspective. .
Direct and positive experience in communicating with Regulatory Authorities and Distributors.
Regulatory review of promotional marketing materials, press releases, labeling, etc.
Desired Profile :
High energy level; positive attitude; works well under stress, Strong communicator
Hands-on, action-oriented, and able to implement effectively through his/her team
Continuous improvement minded; familiar with balancing the need for Quality and the need for efficiency
Able to work autonomously in a matrix-managed organization
Willingness to travel (~0-15%)
Comfortable with ambiguity and change
Good business sense for what’s practical and what’s not. Able to effectively operate in a cost-conscious environment.
We are a science company.
Life Technologies, a global biotechnology leader created through the merger of Invitrogen and Applied Biosystems, creates the brilliant instruments and lab essentials that enable researchers and scientists around the world solve some of the most difficult health, security, food and energy problems of the 21 st century. We believe in the power of science to transform life and the power of people to make it happen. Everyday we help shape new discoveries that improve life. If you’re ready to make a difference in the world, you can do it here. We invite you to join in to stand out.
A few facts
- We serve three Life Sciences markets: Research Sciences, Medical Sciences and Applied Sciences.
- We are more than 10,000 employees and contractors who are located at 86 facilities in 160 countries.
- Our portfolio includes eight marquee brands and more than 50,000 products.
- Our brands and products can be found in 90% of U.S. labs.
- Our 2011 net sales totaled $3.7 billion.
- We hold more than 4,000 patents and have received more than 600,000 citations.
- We are the top supplier of stem cell research consumables and the world’s largest supplier of human identification testing and forensic DNA analysis tools.
What it’s like to work at Life Technologies
- You work for a company with a very a promising future.
- You work in a culture of continuous improvement—exciting and fast-paced.
- You work with great people and great minds.
- You work with people who value diversity because they know they are stronger together.
- You have the freedom define your own destiny.
- You share a common purpose with your teammates: Shaping Discovery. Improving Life. Life Technologies is an equal opportunity employer. We encourage you to apply, regardless of race, religion, color, sex (including pregnancy), age, disability, national origin or citizenship, marital status, sexual orientation, gender identity and/or expression or veteran's status. Life Technologies is committed to carrying out and complying with all of its EEO and affirmative action obligations under applicable federal, state and local laws and regulations.