Job details
- Location
- Salary
- Negotiable
- Job Type
- Full Time
- Ref
- BBBH35729_1608611952
- Contact
- Angela Barclay
- Posted
- over 3 years ago
Job details
- Location
- Salary
- Negotiable
- Job Type
- Full Time
- Ref
- BBBH35729_1608611952
- Contact
- Angela Barclay
- Posted
- over 3 years ago
Benefits
Responsibility for a large portfolio with high class devices
Part of a high performing team where the members have tenure in their service to the company
Development opportunity to manage
Reports to an established manager who is highly supportive and pro-development
Flexible, work/life balance
About the company
Delivers excellence in providing product innovation, customer focus, research to real-life solutions and medicines that improve and save lives. Our client set a space where you can be inspired by the many people who have encouraged and made it their life's work to investigate, develop and educate.
About the Opportunity
The Regulatory Affairs Associate role will hold responsibility for a portfolio of products including many higher-class devices. Reporting to the Regulatory Affairs Manager this will be an autonomous role with a view to developing to people management.
Duties
Preparation and submission of regulatory documents for large orthopaedics portfolio for both new and existing products
Develop strong relationships with internal stakeholders and regulators
Maintain regulatory databases both departmental and for the wider company source
Contribute to industry working groups, assisting to shape the healthcare environment
Provide regulatory support during internal and external audits
Represent the regulatory department on cross functional project teams
Assist in training Regulatory Associates in addition to supporting the wider business with product portfolios
Skills and Experience
BSc or BEng with minimum 5 years regulatory experience working with medical devices
Regulatory submissions of higher-class medical devices where joint registration would be highly desirable
Experience with conformity assessment
Familiar with portfolios with a large volume of products
Life cycle management
Desire to develop to a people manager with the ability to mentor juniors
Strong stakeholder management
Culture
Committed to caring, passionate about doing what's right. A culture that enables dynamic and impactful careers. Thrives on collaboration, inclusion, the sharing and refinement of critical skills and methods.
How to Apply
Click apply or contact Angela Barclay on 02 8877 8743 for a confidential discussion.
( SK915184A )
Similar jobs
4 months ago
Regulatory Affairs
Senior Regulatory Affairs Associate
- Sydney
- Attractive salary and benefits package
Benefits• A role for an experienced Regulatory Affairs professional.• Opportunity for career development and progression within the team.• Part time option available and competitive salary package on offer.About the companyOur client is a leading regulatory consultancy - they are renowned locally and have a strong presence in the nationa...
2 months ago
Regulatory Affairs
Senior Regulatory Affairs Associate
- Sydney
- Competitive salary package + beneifts
Benefits• Work with a leading Healthcare company with a global presence• Collaborative environment with a supportive team in place• Competitive salary package + bonusAbout the CompanyOur client is a leading medical devices company in Australia with a global presence focusing on life-changing technologies with leading products across Medi...