Senior Regulatory Affairs Specialist required for exciting new opportunity with medical device company in Central Belt of ScotlandAre you an experienced Regulatory Affairs professional looking...
Senior Regulatory Affairs Specialist required for exciting new opportunity with medical device company in Central Belt of Scotland
Are you an experienced Regulatory Affairs professional looking for a new challenge?
Do you have a strong background in medical devices?
SRG is working with a leader in medical devices to recruit a Senior Regulatory Affairs Specialist to undertake a dynamic and challenging role to support regulatory compliance allowing products to be marketed globally. Reporting to the Director, you will be an enthusiastic and driven Regulatory Affairs Specialist, with hands on experience in regulatory affairs within medical devices.
My client offers you a competitive salary and benefits package with the potential for development and skills improvement.
ROLE / DESCRIPTION
- Managing and driving regulatory projects.
- Provide regulatory expertise in the development and registration of products.
- Communicate effectively with external and internal parties, building strong relationships.
- Advise clients on strategy plans for assigned projects.
- Responsible for driving 510k, CE and other regulatory documentation and submissions.
- Preparation and Participation in meetings with relevant Competent Authorities.
- Working with CROs on paths to market for new technologies through extensive research.
- Keeping the business up to date with the latest developments in global regulations.
- Provide regulatory guidance in the development and validation of new and existing products.
- Degree in science, engineering or quality subject or equivalent work experiences.
- Practical experience of regulatory submissions and requirements within a medical device industry, experience in ISO9001 and ISO13485 is essential.
- You must have knowledge of FDA & MHRA systems and procedures as well as cGMP / Quality System Regulations and testing medical products to performance standards.
- You will also have direct experience with Medical Device approvals, particularly clinical trial requirements.
- Excellent presentation skills are required as is good computer skills.
SRG is the UK's number one recruitment company specialising in the scientific, engineering, clinical, pharmaceutical, food/FMCG, energy & renewables, biotech, chemical and medical device sectors.
As scientists ourselves, our specialist sector knowledge and our passion are second to none. It's this combination that makes us different. We're committed to providing excellent temporary, contract and permanent career opportunities of all levels for our candidates and a comprehensive range of expert strategic recruitment services for our clients.
To apply for this position, please use the link provided. For more information regarding this position or any others, please contact Pamela.
If you have a scientific background and this position is not relevant / suitable for you please feel free to get in touch or visit www.srg.co.uk to view our other vacancies.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, ethnicity, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Keywords: medical devices, ISO9001, ISO13485, FDA, MHRA, regulatory affairs, submissions, GMP, quality, clinical trial, approvals
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.