Regulatory Affairs Specialist

Salary Range for Regulatory Affairs Specialist in Surgical and Medical Instrument Manufacturing

Salary Range for Regulatory Affairs Specialist in Surgical and Medical Instrument Manufacturing: $60,000 - $100,000 per year.

Sample Job Description for Regulatory Affairs Specialist in Surgical and Medical Instrument Manufacturing Industry

Job Description:

The Regulatory Affairs Specialist Plays A Crucial Role In Ensuring Compliance With Regulatory Requirements And Standards For Surgical And Medical Instrument Manufacturing. They Are Responsible For Developing And Implementing Strategies To Obtain And Maintain Regulatory Approvals For The Company'S Products. This Involves Conducting Thorough Research On Applicable Regulations, Preparing And Submitting Regulatory Submissions, And Managing Interactions With Regulatory Authorities.

Job Requirements:

1. Bachelor'S Degree In A Related Field (E.G., Life Sciences, Engineering, Or Pharmacy). 2. Strong Knowledge Of Medical Device Regulations, Such As Fda Regulations, Iso Standards, And European Medical Device Regulation (Mdr). 3. Experience In Regulatory Affairs Within The Medical Device Industry. 4. Proficient In Interpreting And Applying Regulatory Requirements To Product Development Activities. 5. Excellent Attention To Detail And Organizational Skills. 6. Strong Written And Verbal Communication Skills. 7. Ability To Work Collaboratively With Cross-Functional Teams. 8. Familiarity With Quality Management Systems And Documentation Practices. 9. Knowledge Of Clinical Evaluation And Post-Market Surveillance Processes. 10. Understanding Of Risk Management Principles In Medical Device Development.

Job Responsibilities:

1. Develop And Implement Regulatory Strategies To Ensure Compliance With Applicable Regulations. 2. Prepare And Submit Regulatory Submissions, Including 510(K) Applications, Ce Marking Applications, And Technical Files. 3. Review And Approve Labeling, Advertising, And Promotional Materials For Compliance With Regulations. 4. Collaborate With Cross-Functional Teams To Ensure Regulatory Requirements Are Incorporated Into Product Development Processes. 5. Conduct Regulatory Research And Stay Updated On Changes In Regulations And Standards. 6. Coordinate And Support Regulatory Inspections And Audits. 7. Maintain Regulatory Documentation And Files. 8. Provide Regulatory Guidance And Training To Internal Stakeholders. 9. Participate In Regulatory Reviews And Assessments Of Product Changes And Modifications. 10. Monitor And Assess Post-Market Surveillance Data And Address Any Regulatory Issues Or Concerns.

Top 10 Employers for Regulatory Affairs Specialist in Surgical and Medical Instrument Manufacturing:

1. Johnson & Johnson - HQ Location: New Brunswick, New Jersey, USA - Website: www.jnj.com 2. Medtronic - HQ Location: Dublin, Ireland - Website: www.medtronic.com 3. Abbott Laboratories - HQ Location: Abbott Park, Illinois, USA - Website: www.abbott.com 4. Stryker Corporation - HQ Location: Kalamazoo, Michigan, USA - Website: www.stryker.com 5. Boston Scientific Corporation - HQ Location: Marlborough, Massachusetts, USA - Website: www.bostonscientific.com 6. Zimmer Biomet - HQ Location: Warsaw, Indiana, USA - Website: www.zimmerbiomet.com 7. Becton, Dickinson and Company (BD) - HQ Location: Franklin Lakes, New Jersey, USA - Website: www.bd.com 8. Philips Healthcare - HQ Location: Amsterdam, Netherlands - Website: www.philips.com/healthcare 9. Siemens Healthineers - HQ Location: Erlangen, Germany - Website: www.siemens-healthineers.com 10. Olympus Corporation - HQ Location: Tokyo, Japan - Website: www.olympus-global.com

Career Path for Regulatory Affairs Specialist in Surgical and Medical Instrument Manufacturing:

1. Regulatory Affairs Associate - Bachelor's degree in a related field, 2-3 years of experience 2. Regulatory Affairs Specialist - Bachelor's degree in a related field, 3-5 years of experience 3. Senior Regulatory Affairs Specialist - Bachelor's degree in a related field, 5-8 years of experience 4. Regulatory Affairs Manager - Bachelor's degree in a related field, 8-10 years of experience 5. Director of Regulatory Affairs - Bachelor's degree in a related field, 10+ years of experience

Top 5 Countries by Regulatory Affairs Specialist in Surgical and Medical Instrument Manufacturing:

1. United States 2. Germany 3. United Kingdom 4. Canada 5. Switzerland

Top 5 Countries with Established Surgical and Medical Instrument Manufacturing:

1. United States 2. Germany 3. Japan 4. China 5. Switzerland