Senior Regulatory Reporting Specialist
Allstaff Recruitment – Elstree
Salary: £35,400 circa per annum
Allstaff Recruitment have the pleasure of working with a niche and leading global organisation to recruit a Senior Regulatory Reporting Specialist.
As the Senior Regulatory Reporting Specialist, you will be reviewing and assessing all incoming product complaints according to the regulatory requirements and ensuring all required reports are completed and submitted to the applicable agency.
- Review reports of customer complaints and assess them for MDR / MDV reportability to FDA / Competent Authorities
- Ensure initial and follow up reports are submitted to Regulatory Agencies within required timelines.
- Review and approve regulatory filing decisions.
- Interact with Regulatory Agencies to assure their questions are addressed within established timeframes
- Partner with Quality Complaint-Handling personnel to assure the complaint records contain all required information to make a compliant regulatory decision
- Ensure complaints are classified correctly and that all supporting data are adequately documented and attached to the complaint file
- Act as mentor for less experienced employees in the area of adverse event reporting
- Update current procedures/processes or create new procedures/processes
- Work from verbal and/or written instructions
- Track metrics on process timeliness and effectiveness
- Participate and/or lead process improvement projects
- Train and mentor new and/or less experienced employees as well as cross functional partners in the process
- May provide adverse event reporting data for product recalls and recall communications.
Qualification and skills required:
- Bachelor’s Degree in Science, Engineering, Legal, or Regulatory and/or 3+ years’ experience as a Regulatory or Quality professional.
- 3+ years’ experience as a Regulatory or Quality professional in a regulated manufacturing environment.
- Experience with MDR/MDV reporting
- Demonstrated organisational, problem-solving, analytical and time management skills
- Demonstrated interpersonal skills required to interface with technical and non-technical personnel at all levels of the organisation
- Demonstrated ability to effectively communicate through written and oral means on behalf of the department
- Ability to respond to the urgent needs of the department as well as the ability and versatility to adapt to changing priorities
- Proven track-record for meeting deadlines and delivering results
- Experience in technical/procedure writing is preferred
- Demonstrated ability to exhibit a positive, energetic approach to teamwork.
- Proficient with Microsoft Office and ability to learn Corporate systems
- Proficiency with TrackWise is preferred.
- Ability to read and interpret Engineering schematics / drawings / prints is preferred.
- Positive, energetic approach to teamwork and an advocate for quality.
To apply for the Senior Regulatory Reporting Specialist role, please complete your details below and include a copy of your up to date CV.
**Thank you for your interest in this role, your application will now be reviewed by one of our qualified consultants. Due to the high volume of applications Allstaff Recruitment receive, it is with regret we are unable to respond to all candidates directly. However, if you do not hear from us within seven days, you have unfortunately been unsuccessful on this occasion.
Allstaff Recruitment is an Independent Recruitment Specialist acting as an employment agency and an employment business, specialising in permanent, contract and temporary placements across a vast number of industries. If you are looking for Jobs in Bedford, then look no further than Allstaff Recruitment for a variety of different roles across numerous industries. When looking for recruitment in Bedford, Allstaff Recruitment is genuinely interested in both our candidates and clients and aims to find the best match for you. Our ethos is simple: to build long term relationships by offering an exceptional recruitment service at all times. As a member of the REC, Allstaff Recruitment is committed to working to the highest possible standards. **