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Director of Global Regulatory Affairs

Company: Sterling Life Sciences
Location: Sterling
Posted on: September 13, 2020

Job Description:

Sterling-Hoffman Executive Search Located in: Maryland

A leading company in the medical device industry is currently seeking a Director of Global Regulatory Affairs to join their team. The role will be challenging but also highly rewarding and this leader will be a key voice in the company. For the right executive, this is a fantastic opportunity with great growth prospects. Key duties include:

1) Assist in the development of global regulatory strategy to obtain rapid approvals with favorable indications for company’s products

2) Ensure compliance with applicable rules and regulations across the organization

3) Ensure that effective relationships with global regulatory bodies

4) Examine and develop global regulatory pathways and timelines and work with internal and external stakeholders

5) Administer core regulatory processes, including claims review, label development and literature review

6) Execute optimal submission process and ensure continuous improvement

7) Maintain regulatory records, including submissions and correspondence with global regulatory bodies

8) Comply with company’s policies and procedures

9) Maintain internal regulatory documents and product registration files

10) Manage regulatory reporting activities

11) Take a part in key cross-functional activities, including clinical strategy development, product lifecycle management and marketing review

12) Design and implement processes for gathering global regulatory intelligence and raise awareness within the organization of current trends in regulatory development and enforcement

13) Provide strategic and operational guidance across all levels within company as well as with external vendors

14) Perform other duties as assgined

CRITICAL REQUIREMENTS 1) A university degree is required. Although all candidates are welcome and encouraged to apply, preference will be given to those with degrees in a relevant field

2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)

3) Recent experience in the medical device industry is strongly preferred

4) Preference will be given to candidates with recent experience in regulatory affairs management

If you are qualified and looking to work with a well-established company – one of the top names in the industry – you should not let this opportunity pass by. However, for this Director, Global Regulatory Affairs role, you must be someone who is experienced and passionate about regulatory affairs management.

COMPANY INFORMATION Sterling-Hoffman is a retained executive search firm that specializes in representing life sciences and technology companies in matters of high impact talent acquisition. Our clients include market leaders and venture capital-backed startups in industries such as: medical device, biotechnology, pharmaceuticals, enterprise software, clinical research, and laboratory services. You may view more of our jobs here: http://www.sterlinglifesciences.com Your privacy is important to us: we will never share your resume without your permission. Please note that only qualified applicants will receive a response. We encourage you to apply for as many jobs as you believe you are a fit for, but strongly suggest that you include your salary information as job seekers who provide salary information are likely to be reviewed sooner. ===================== TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Biotechnology Recruiter, Pharmaceutical Recruiter, Medical Device Recruiter, Biotechnology Career, Clinical Research Job, Regulatory Affairs Job, R&D / Scientist Job, Product Manager Job, Medical Device Sales Job, Biotechnology Sales Job, Quality Assurance Job, Engineering Job, Laboratory Jobs, Microbiology Jobs, CEO Jobs, Marketing Jobs, Manufacturing Jobs, Oncology Jobs, Cardiology Jobs, Hematology Jobs, Medical Jobs

Keywords: Sterling Life Sciences, Sterling , Director of Global Regulatory Affairs, Other , Sterling, Virginia

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