Our client, a foremost leader in biotechnology with over $15 billion in sales revenue and 50,000 employees world-wide wants your talent and expertise on their team!
We are seeking an experienced Senior Manager of Regulatory Affairs to be part of a growing team in the Global Regulatory Department. Working remotely, the Senior Manager will oversee market regulatory reporting requirements and manage product changes. Our client offers a competitive base salary, an attractive bonus plan and an exciting career track.
If you have a bachelor’s degree in Biology, Chemistry, Bio-engineering or related science and a minimum of 5 years of IVD Regulatory Affairs experience, please submit your resume in Word format to [email protected].
RESPONSIBILITIES:
- Responsible for providing managerial and individual guidance to assure that post market regulatory reporting requirements are met
- Ensure oversight of product changes are assessed to determine impact of product changes for on market products
- Make sure ex-US registrations are planned and executed in accordance with business need
- Deliver regulatory guidance to project teams and external partners
- Perform 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
- Assist Regulatory department in the update, enhancement, and creation of internal policies and procedures.
- 7 or more years of IVD Regulatory Affairs experience.
- A bachelor’s degree in Biology, Chemistry, bio-engineering or related science at a minimum, with advanced degree preferred
- 2 or 3 years of Management experience including either 510 (k), PMA, or PMA supplement submissions
QUALIFICATIONS:
- Must be well versed in the aspects of regulatory strategy creation, design control, cGMP / Quality Systems, and import / export requirements
- Experience as the RA representative on project core teams providing active and successful regulatory guidance and RA strategies
- Experience in the balance and application of regulatory requirements
- Direct and positive experience in communicating with Regulatory Authorities and co-development partners
- Background with Regulatory review of promotional marketing materials, press releases, labeling
- Demonstrate in-depth understanding of advanced technical / scientific principles related to IVD reagent chemistry, laboratory automation, and software components of IVD medical devices
- Possess the ability to effectively communicate regulations to technical functions within the company
- Must possess a high energy level and maintain a positive attitude even when working under stress
- Be a strong communicator and leader
- 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
- Ability to provide solutions based on knowledge of regulation and industry experience
- Willingness to travel (~ 10-15%)
- Comfortable with ambiguity and change