Regulatory Affairs Consultant
Excellent Opportunity for a Sr. Regulatory Affairs Consultant in Andover
In this role, you have the opportunity to guide and support the EU MDR Program and the Business Groups in EU regulations.
This involves being a confident advisor on regulatory strategy, lobbying, regulatory compliance and quality management related topics, in order to achieve systems and
product compliance to the EU MDR by May 2020 and IVD by May 2022 as well as to support other laws, regulations and standards impacting safe and effective utilization in the EU.
Your responsibilities will include but are not limited to the following:
- Own and drive activities within the EU MDR Program as a Subject Matter Expert. Define and support training with information/guidance documents on MDD/MDR/IVDR/MEDDEV 2.7/rev4 as appropriate within the businesses and
supporting functions. Consultation on MDR/IVDR (internally & externally) to drive the client's position and maintain awareness of industry (competitor) positioning
- Help identify key priorities and decisions to enable the organization to capture key opportunities to reduce risk and improve performance on implementation of EU MDR/IVDR Program
- Monitor the implementation of the new EU MDR/IVDR requirements and identify any key risk areas and mitigation activities within business and supporting functions to ensure compliance prior to May 2020 and May 2022 deadlines.
- Support standards team on analysis, interpretation and dissemination of information as it applies to the EU MDR.
- Serve on national and international standards committees and industry organizations that establish or influence requirements on medical products/solutions (i.e. Participate in COCIR and MedTech Europe representing the client and Leadership in Key Committee(s) representing industry)
- Leverage well developed interpersonal skills to build and maintain positive working relationships with functional groups throughout the organization
- Support internal program and external client communication, which includes content and planning for communications cascades, and supporting review / feedback.
You are a part of
You are part of the the client's Global Regulations & Standards (GR&S) team, which is critical to interpret, influence, and apply worldwide regulations and standards to the client.
The role reports solid line to the EU MDR / IVDR program director within GR&S and dotted line to the Head of Global Regulations & Standards
To succeed in this role, you should have the following skills and experience
* Bachelor's degree in science,engineering/technology or related field, Master's degree preferred.
* Min 7+ years of experience with working knowledge of global medical device regulations, requirements
* Viewed as an expert within EU Regulations, with proven experience in implementation and use of EU Medical Device
* Directive, In Vitro Diagnostic Directive, Low Voltage Directive and Radio Equipment Directive and knowledge and interpretation of the differences in the EU MDR Medical Device Regulations.
* Knowledge and expertise in Quality Management Systems and Risk Management Standards - ISO 13485 and ISO 14971.
* Strong executive presence; ability to influence multiple levels of stakeholders and management
* Demonstrated track record of team leadership, building teams, relationship management, and business development,
including virtual teams
* Strong communication, interpersonal and presentation skills; detail-oriented
* Proven experience in a matrix management of multiple operations
* Ability and willingness to travel both domestically and internationally up to 25% of the time